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510(k) Data Aggregation

    K Number
    K243499
    Device Name
    NG-Test® CTX-M MULTI
    Manufacturer
    NG Biotech
    Date Cleared
    2025-06-04

    (204 days)

    Product Code
    PTJ
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    NG Biotech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production when grown on the following media: - 5% sheep blood agar or MacConkey agar (16-24 hours) - HardyCHROM™ ESBL agar (18-24 hours) The NG-Test® CTX-M MULTI is intended as an aid for infection control in the detection of CTX-M enzymes-producing organisms (Enterobacterales) in healthcare settings. NG-Test® CTX-M MULTI is not intended to guide or monitor treatment. A positive or negative NG-Test® CTX-M MULTI test result does not rule out the presence of other mechanisms of antibiotic resistance. NG-Test® CTX-M MULTI should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.
    Device Description
    NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production after culturing on agar and processed in an extraction buffer. The device consists of a sample port, sample and conjugate pad, and nitrocellulose test strip, which are contained within a plastic cassette, in addition to reagents for liquid extraction. The result can be read 15 minutes after adding the sample to the sample well. A positive result on the NG-Test® CTX-M MULTI occurs when two red lines appear, one on the control (C) region and one on the test (T) region. A negative result occurs when only the control line is observed and indicates the sample does not contain any target CTX-M enzymes, or the CTX-M enzymes are present at a non-detectable level. If the control line does not appear, the test result is invalid. Monoclonal antibodies that recognize the five major CTX-M groups are immobilized on a nitrocellulose membrane. Free monoclonal antibodies are present in the conjugate pad and labeled with colloidal gold. Upon addition of the processed sample to the sample pad, the capillary action of the nitrocellulose draws the sample through the mobile antibodies in the conjugate pad and the immobile antibodies on the test strip. The immobilized control antibodies capture any mobile antibodies that do not bind to the test line.
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    K Number
    K250067
    Device Name
    Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
    Manufacturer
    Guangzhou Decheng Biotechnology Co., Ltd.
    Date Cleared
    2025-02-20

    (41 days)

    Product Code
    NGL, NFT, NFV, NFW, NFY, NGG, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Decheng Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a postive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup Pro is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations. Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    Dochek® Multi-Drug Urine Test Cup Pro and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic medical devices. This device is a cup format, with the test strips integrated into the plastic cup provided, and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed in an aluminum foil pouch with two sachets of desiccant. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K242428
    Device Name
    Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
    Manufacturer
    Guangzhou Decheng Biotechnology Co., Ltd.
    Date Cleared
    2025-02-06

    (175 days)

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

    Guangzhou Decheng Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine. Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.
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    K Number
    K241454
    Device Name
    Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
    Manufacturer
    Guangzhou Hehong Biotech Co., Ltd.
    Date Cleared
    2025-02-03

    (257 days)

    Product Code
    MQK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Hehong Biotech Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.
    Device Description
    The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are intended for use in closed vitrification procedures to contain and maintain human oocytes (MI), 4-8 cell embryos, and blastocyst stage embryos, and they are intended for use in professional healthcare facilities. The subject devices are for single use, disposable and supplied sterile. The Minvitro® Vitrification Straws (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are all composed of a cap with a balancing head, a handle, a carrier sheet with a fine tip at the end. The oocytes or embryos are loaded on the carrier sheet, and in which, the fine tip of carrier sheet is flat with a triangular-shaped area for oocyte/embryo loading. The subject devices are sterilized using ethylene oxide (EO) to a sterilization assurance level of 106, are singleuse, and have a 2-year shelf-life. The subject devices are available in five colors: MVT-VSNR. MVT-VSNY. MVT-VSNB. MVT-VSNG, and MVT-VSNP corresponding to Red, Yellow, Blue, Green, and Purple, respectively, all identical in size.
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    K Number
    K240643
    Device Name
    MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
    Manufacturer
    Guangzhou Decheng Biotechnology Co., Ltd.
    Date Cleared
    2024-06-21

    (106 days)

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

    Guangzhou Decheng Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MissLan® Early Detection Pregnancy Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. 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. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only. MissLan® Early Detection Pregnancy Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. 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. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only. MissLan® Early Detection Pregnancy Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. 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. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only.
    Device Description
    MissLan® Early Detection Pregnancy Test will be sold in Strip. Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode. MissLan® Early Detection Pregnancy Test Strip. MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper and urine collection cup. The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
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    K Number
    K240698
    Device Name
    Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
    Manufacturer
    Guangzhou Decheng Biotechnology Co., Ltd.
    Date Cleared
    2024-05-10

    (57 days)

    Product Code
    DJG, DIO, DIS, DJC, DJR, DKZ, JXM, JXN, LCM, LDJ, LFG, NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Decheng Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations: Amphetamine (AMP) 1000 or 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Methamphetamine (MET) 1000 or 500 ng/mL Morphine (MOP/OPI) 300 or 2000 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 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Dochek® Multi-Drug Urine Test Dipcard Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations: Amphetamine (AMP) 1000 or 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Methamphetamine (MET) 1000 or 500 ng/mL Morphine (MOP/OPI) 300 or 2000 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 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Dochek® Multi-Drug Urine Test Dipcard offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    Dochek® Multi-Drug Urine Test Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are singleuse in vitro diagnostic devices. This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K232659
    Device Name
    Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
    Manufacturer
    Guangzhou Decheng Biotechnology Co., Ltd.
    Date Cleared
    2023-12-13

    (104 days)

    Product Code
    DJG, DIO, DIS, DJC, DJR, DKZ, JXM, JXN, LCM, LDJ, LFG, NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Decheng Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result,particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result,particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    Dochek® Multi-Drug Urine Test Cup Rx and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a cup format. The test strips are integrated into the cup provided and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K230038
    Device Name
    MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
    Manufacturer
    Guangzhou Decheng Biotechnology Co., Ltd.
    Date Cleared
    2023-02-28

    (53 days)

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

    Guangzhou Decheng Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use. MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
    Device Description
    MissLan® Pregnancy Rapid Test will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum pouch, Urine Collection Cup and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
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    K Number
    K222305
    Device Name
    MissLan™ Digital Pregnancy Rapid Test
    Manufacturer
    Guangzhou Decheng Biotechnology Co. Ltd.
    Date Cleared
    2022-11-30

    (121 days)

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

    Guangzhou Decheng Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MissLan™ Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
    Device Description
    MissLan™ Digital Pregnancy Rapid Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.
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    K Number
    K221454
    Device Name
    Disposable Medical Nitrile Examination Gloves - Non Sterile
    Manufacturer
    Guangzhou Kangling Biotechnology Co., Ltd
    Date Cleared
    2022-07-12

    (54 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Kangling Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Disposable Medical Nitrile Examination Gloves (Non Sterile)
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