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510(k) Data Aggregation

    K Number
    K241317
    Device Name
    Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2024-09-30

    (143 days)

    Product Code
    QYT
    Regulation Number
    866.3984
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Wondfo Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a visually read lateral flow immunoassay test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established from April, 2023 to February, 2024 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
    Device Description
    The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a lateral flow immunoassay intended for non-prescription home use qualitative detection of nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first five (5) days of symptom onset. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with two lines: a test line (T line) and a control line (C line). The device is for in vitro diagnostic use only. The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) consists of the following components: - . Tube Holder (located in kit box) - Test Cassette ● - Tube (pre-filled extraction buffer) ● - Swab ● - Quick Reference Instructions ●
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    K Number
    K241741
    Device Name
    SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2024-07-16

    (29 days)

    Product Code
    NGL
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Wondfo Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. For Over The Counter (OTC) use. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ Fentanyl (FTY) Urine Test Cassette is a competitive binding, lateral flow immunochromatoqraphic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. lt is not intended to distinquish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. For Over The Counter (OTC) use. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method. The SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL. For in vitro diagnostic use. It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/ MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
    Device Description
    The Wondfo SAFElife™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each Wondfo SAFElife™ Fentanyl Test consists of a Test Device in format of Cassette or Dip Card, and a package insert. Each Test Device is sealed with sachets of desiccant in an aluminum pouch.
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    K Number
    K202567
    Device Name
    Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2020-09-25

    (21 days)

    Product Code
    NFT, LCM, NFV, NFW, NFY, NGG, NGL, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Wondfo Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wondfo T-Dip® Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedoxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Cannabinoids (THC 50) | 50 ng/mL | Wondfo T-Dip® Multi-Drug Urine Test Panel offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. Wondfo T-Dip® Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Cannabinoids (THC 50) | 50 ng/mL | Wondfo T-Dip® Multi-Drug Urine Test Panel Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    The Wondfo T-Dip® Multi-Drug Urine Test Panel and Wondfo T-Dip® Multi-Drug Urine Test Panel Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test T-Dip® panel and two desiccants, and a package insert. The Wondfo T-Dip® Multi-Drug Urine Test Panel is intended for over-the-counter use and the Wondfo T-Dip® Multi-Drug Urine Test Panel Rx is intended for prescription use.
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    K Number
    K182701
    Device Name
    Wondfo T-Cup Multi-Drug Urine Test Cup
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2018-12-03

    (67 days)

    Product Code
    NFT, LCM, NFV, NFW, NFY, NGG, NGL, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Wondfo Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wondfo T-Cup® Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |----------------------------------------------------------|-------------------------| | Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Oxazepam (BZO) | 300 ng/mL | | Cocaine (COC) | 300 ng/mL or 150 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Cannabinoids (THC 50) | 50 ng/mL | Wondfo T-Cup® Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only, The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    Wondfo T-Cup® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine. Each T-Cup® Multi-Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with two sachets of desiccant in an aluminum pouch.
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    K Number
    K173229
    Device Name
    Preview Digital Pregnancy Test
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2018-03-12

    (159 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Wondfo Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Preview® Digital Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
    Device Description
    Preview® Digital Pregnancy Test is designed to be tested in dip and midstream modes. Preview® Digital Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K162333
    Device Name
    Wondfo One Step Fecal Occult Blood (FOB) Test
    Manufacturer
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Date Cleared
    2017-05-14

    (265 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUANGZHOU WONDFO BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal(GI) bleeding. The device is suitable for use in laboratories and physician's offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use.
    Device Description
    The Wondfo One Step Fecal Occult Blood Test utilizes double antibodies sandwich immunoassay for the detection of hemoglobin in test samples. The test kit consists of: Test devices, one test in one pouch. One pouch contains a test cassette and a desiccant. The desiccant is for storage purposes only and is not used in the test procedures. Collection tubes with 1.5mL extraction buffer solution. Clean collection papers. Instructions for use.
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    K Number
    K161214
    Device Name
    Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
    Manufacturer
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Date Cleared
    2016-06-27

    (59 days)

    Product Code
    DIO, DJC, DKZ
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUANGZHOU WONDFO BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wondfo Amphetamine Urine Test AMP 500 Cup is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Amphetamine Urine Test AMP 500 DipCard is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Cocaine Urine Test COC 150 Cup is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Cocaine Urine Test COC 150 DipCard is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Methamphetamine Urine Test MET 500 Cup is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Wondfo Amphetamine Urine Test MET 500 DipCard is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator). The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
    Device Description
    WONDFO Urine Test devices are immunochromatographic assays for cocaine, amphetamine and Methamphetamine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups. It contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.
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    K Number
    K152495
    Device Name
    Wondfo Propoxyphene Urine Test
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2015-11-23

    (83 days)

    Product Code
    JXN
    Regulation Number
    862.3700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Wondfo Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a test cup format. It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drug d-Propoxyphene is ingested, even at or above therapentic doses. There is no uniformly recognized cutoff concentration for d-Propoxyphene. It is not intended to distinguish between prescription use or abuse of this drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    The Wondfo Propoxyphene Urine Test uses immunochromatographic assays for d-Propoxyphene. The test is a lateral flow system for the qualitative detection of d-Propoxyphene in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
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    K Number
    K150022
    Device Name
    Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2015-08-07

    (213 days)

    Product Code
    LCX, JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Wondfo Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wondfo One Step HCG Urine Pregnancy Test Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (bCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This product is intended for both prescription use and over-the-counter use. Wondfo One Step HCG Urine Pregnancy Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This product is intended for both prescription use and over-the-counter use. Wondfo One Step HCG Urine Pregnancy Test Midstream is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This product is intended for over-the-counter use.
    Device Description
    Each of the devices (strip, cassette, and midstream) contains a pouch with the test and instructions. The cassette and midstream nitrocellulose test strips are contained in plastic housing. The cassette test also contains a dropper. The strips of each device contain mouse monoclonal anti-β-hCG antibody colloidal gold conjugate pre-dried on the pad, mouse monoclonal anti-u-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line).
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    K Number
    K151478
    Device Name
    Wondfo CR3 Keyless Split Sample Cup
    Manufacturer
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Date Cleared
    2015-07-01

    (29 days)

    Product Code
    DJG, DIO, DIS, DJR, DKZ, JXM, LAF, LCM, LDJ, LFG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUANGZHOU WONDFO BIOTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of: | Drug(Identifier) | Cut-off level | |-------------------------------|-------------------------| | Amphetamine | 1000 ng/mL | | Secobarbital | 300 ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 300 ng/mL | | Cannabinoids | 50 ng/mL | | Methamphetamine | 1000 ng/mL | | Methylenedioxymethamphetamine | 500 ng/mL | | Morphine | 300 ng/mL or 2000 ng/mL | | Phencyclidine | 25 ng/mL | | Oxycodone | 100 ng/mL | | Buprenorphine | 10 ng/mL | | Methadone | 300 ng/mL | | Notriptyline | 1000ng/mL | Configuration of the Wondfo CR3 Keyless Split Sample Cup can consist of any combination of the above listed drug analytes. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drugs Buprenorphine. Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    The Wondfo CR3 Keyless Split Sample Cup uses immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in human urine samples. The test is a lateral flow, competitive binding system. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
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