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510(k) Data Aggregation
K Number
K242576Device Name
AllTest Viral Transport Medium
Manufacturer
Hangzhou Alltest Biotech Co.,Ltd
Date Cleared
2025-04-04
(218 days)
Product Code
JSM
Regulation Number
866.2390Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Alltest Biotech Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Viral Transport Medium (VTM) is intended for collection and transport of clinical specimens containing viral agents including Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from collection site to the testing laboratory. Specimens collected in the AllTest VTM can be processed using standard clinical laboratory operating procedure for viral culture.
The AllTest Viral Transport Medium is also intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing SARS-CoV-2 nucleic acid. The AllTest VTM is suitable for use with compatible legally marketed molecular diagnostic devices.
Device Description
The AllTest Viral Transport Medium (VTM) device is comprised of a screw cap polypropylene tube filled with 3 mL VTM. The VTM tube is tightly closed with a polyethylene cap. The AllTest VTM contains Hank's Balanced Buffer solution (HBBS), proteins, sugar, and antimicrobials to provide stability to live viruses. The AllTest VTM also contains a pH indicator (phenol red) to provide a visual check on medium pH. The VTM appears clear and red in color. The packaging also includes a biohazard specimen bag.
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K Number
K250727Device Name
AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
Manufacturer
Hangzhou Alltest Biotech Co.,Ltd
Date Cleared
2025-04-04
(24 days)
Product Code
NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW, QBF
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Alltest Biotech Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|-------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepine (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL or 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs 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.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|-------------------|------------|-----------------|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepine (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl (FYL) | Fentanyl | 1 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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
AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid 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 devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.
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K Number
K244043Device Name
AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
Manufacturer
Hangzhou Alltest Biotech Co.,Ltd
Date Cleared
2025-02-27
(59 days)
Product Code
NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW, QBF
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Alltest Biotech Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---------------------------------------------------------------------------------------------|-------------------|
| Amphetamine (AMP) | 500 or 1000 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Benzodiazepines (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 or 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 or 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 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 |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
| AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination | |
est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. 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.
AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|--------------------------------------------------------------|-------------------------------------------------------|-----------------|
| Amphetamine (AMP) | d-Amphetamine | 500 or 1000 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 or 300 |
| 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine | 300 |
| Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 or 2000 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 1-nor-Δ9-THC-9 COOH | 50 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Fentanyl(FYL) | Fentanyl | 1 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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
AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a cup format. Each test device is sealed with 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
K242540Device Name
AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
Manufacturer
Hangzhou Alltest Biotech Co.,Ltd
Date Cleared
2024-09-27
(32 days)
Product Code
NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Alltest Biotech Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off leve |
|--------------------------------------------------------------|--------------|
| Amphetamine (AMP) | 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
AllTest Multi-Drug Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs 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.
AllTest Multi-Drug Rapid Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|---------------------|---------------|-----------------|
| Amphetamine (AMP) | d-Amphetamine | 500 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 |
| Methamphetamine (MET) | d-Methamphetamine | 500 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl(FYL) | Fentanyl | 1 |
AllTest Multi-Drug Rapid Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinquish 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
AllTest Multi-Drug Urine Test Panel and AllTest Multi-Drug Rapid Urine Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a panel format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
Ask a Question
K Number
K241428Device Name
AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
Manufacturer
Hangzhou Alltest Biotech Co.,Ltd
Date Cleared
2024-06-17
(28 days)
Product Code
NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Alltest Biotech Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|--------------------------------------|---------------|
| Amphetamine (AMP) | 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP/OPI) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. 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.
AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:
| Drug (Identifier) | Calibrator | Cut-off (ng/mL) |
|--------------------------------------|-----------------------------------|-----------------|
| Amphetamine (AMP) | d-Amphetamine | 500 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Secobarbital (BAR) | Secobarbital | 300 |
| Oxazepam (BZO) | Oxazepam | 300 |
| Cocaine (COC) | Benzoylecgonine | 150 |
| Methamphetamine (MET) | d-Methamphetamine | 500 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 |
| Morphine (MOP/OPI) | Morphine | 300 |
| Methadone (MTD) | Methadone | 300 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Nortriptyline (TCA) | Nortriptyline | 1000 |
| Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 |
| Fentanyl(FYL) | Fentanyl | 1 |
AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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
AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid 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 devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
Ask a Question
K Number
K233019Device Name
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
Manufacturer
Hangzhou AllTest Biotech Co.,Ltd
Date Cleared
2023-12-13
(82 days)
Product Code
DKZ, DIO, DIS, DJC, DJG, DJR, DNK, JXM, LAF, LCM, LDJ, LFG, NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW
Regulation Number
862.3100Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou AllTest Biotech Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethy-3.3-diphenylpvrrolidine. Methylenedioxymethamphetamine. Morphine. Methadone. Oxycodone. Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Drug (Identifier) | Cut-off level ng/mL
---|---
Amphetamine (AMP) | 500 or 1000 ng/mL
Buprenorphine (BUP) | 10 ng/mL
Secobarbital (BAR) | 300 ng/mL
Benzodiazepines (BZO) | 300 ng/mL
Cocaine (COC) | 150 or 300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL
Methamphetamine (MET) | 500 or 1000 ng/mL
Methylenedioxymethamphetamine (MDMA) | 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
Nortriptyline (TCA) | 1000 ng/mL
Marijuana (THC) | 50 ng/mL
AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. 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, Benzodiazepines, Secobarbital, 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 must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Drug (Identifier) | Cut-off level ng/mL
---|---
Amphetamine (AMP) | 500 or 1000 ng/mL
Buprenorphine (BUP) | 10 ng/mL
Secobarbital (BAR) | 300 ng/mL
Benzodiazepines (BZO) | 300 ng/mL
Cocaine (COC) | 150 or 300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL
Methamphetamine (MET) | 500 or 1000 ng/mL
Methylenedioxymethamphetamine (MDMA) | 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
Nortriptyline (TCA) | 1000 ng/mL
Marijuana (THC) | 50 ng/mL
AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. 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, Benzodiazepines, Secobarbital, 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 must be used. GC/MS or LC/MS is the recommended confirmatory method.
AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone. Oxycodone, Phencycligine and Mariiuana in human urine at the cutoff concentrations of:
Drug (Identifier) | Calibrator | Cut-off (ng/mL)
---|---|---
Amphetamine (AMP) | d-Amphetamine | 500 or 1000
Buprenorphine (BUP) | Buprenorphine | 10
Secobarbital (BAR) | Secobarbital | 300
Benzodiazepines (BZO) | Oxazepam | 300
Cocaine (COC) | Benzoylecgonine | 150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300
Methamphetamine (MET) | d-Methamphetamine | 500 or 1000
Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500
Morphine (MOP/OPI) | Morphine | 300 or 2000
Methadone (MTD) | Methadone | 300
Oxycodone (OXY) | Oxycodone | 100
Phencyclidine (PCP) | Phencyclidine | 25
Nortriptyline (TCA) | Nortriptyline | 1000
Marijuana (THC) | 11-nor-A9-THC-9 COOH | 50
AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. 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, Benzodiazepines, Secobarbital, 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.
AllTest Multi-Drug Rapid Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Drug (Identifier) | Calibrator | Cut-off (ng/mL)
---|---|---
Amphetamine (AMP) | d-Amphetamine | 500 or 1000
Buprenorphine (BUP) | Buprenorphine | 10
Secobarbital (BAR) | Secobarbital | 300
Benzodiazepines (BZO) | Oxazepam | 300
Cocaine (COC) | Benzoylecgonine | 150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300
Methamphetamine (MET) | d-Methamphetamine | 500 or 1000
Methylenedioxymethamphetamine (MDMA) | d.l-Methylenedioxymethamphetamine | 500
Morphine (MOP/OPI) | Morphine | 300 or 2000
Methadone (MTD) | Methadone | 300
Oxycodone (OXY) | Oxycodone | 100
Phencyclidine (PCP) | Phencyclidine | 25
Nortriptyline (TCA) | Nortriptyline | 1000
Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50
AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may vield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, 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 AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The AllTest Multi-Drug Rapid Test kit contains a Cup or a Panel device, a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
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K Number
K233417Device Name
AllTest Fentanyl Urine Test Cassette
Manufacturer
Hangzhou AllTest Biotech Co.,Ltd
Date Cleared
2023-10-26
(16 days)
Product Code
NGL
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou AllTest Biotech Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Fentanyl Urine Test Cassette is is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. 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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Device Description
AllTest Fentanyl Urine Test Cassette is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Urine Test Cassette consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
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