Clinical Chemistry › Toxicology Test Systems

Who Makes It in China?

50 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Zhejiang and Shandong, and 11 other provinces. 17 of them are contract manufacturers. Chinese manufacturers are registered for 48 of 271 device types here.

21 of those 48 device types need no premarket submission before sale in the United States. The FDA has recorded 392 recalls across the section’s product codes; the root causes it names most often are Nonconforming Material/Component (119), Process control (41) and Device Design (21).

The Largest Device Types Made in China

The device types with the most Chinese manufacturers are Enzyme Immunoassay, Cannabinoids (18), Test, Opiates, Over The Counter (18), Enzyme Immunoassay, Opiates (17), Test, Methadone, Over The Counter (17) and Devices, Breath Trapping, Alcohol (16). All 48 device types in this section with a Chinese manufacturer, most manufacturers first:

Enzyme Immunoassay, Cannabinoids 18 manufacturers
Test, Opiates, Over The Counter 18 manufacturers
Enzyme Immunoassay, Opiates 17 manufacturers
Test, Methadone, Over The Counter 17 manufacturers
Devices, Breath Trapping, Alcohol 16 manufacturers
Enzyme Immunoassay, Amphetamine 16 manufacturers
Enzyme Immunoassay, Cocaine And Cocaine Metabolites 16 manufacturers
Test, Amphetamine, Over The Counter 16 manufacturers
Test, Barbiturate, Over The Counter 16 manufacturers
Test, Benzodiazepine, Over The Counter 16 manufacturers
Test, Cannabinoid, Over The Counter 16 manufacturers
Test, Cocaine And Cocaine Metabolites, Over The Counter 16 manufacturers
Test, Methamphetamine, Over The Counter 16 manufacturers
Test, Propoxyphene, Over The Counter 16 manufacturers
Test, Tricyclic Antidepressants, Over The Counter 16 manufacturers
Enzyme Immunoassay, Benzodiazepine 13 manufacturers
Test, Methamphetamine, Employment And Insurance Testing, Exempt 13 manufacturers
Enzyme Immunoassay, Barbiturate 12 manufacturers
Test, Cannabinoid, Employment And Insurance Testing, Exempt 12 manufacturers
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt 12 manufacturers
Test, Opiates, Employment And Insurance Testing, Exempt 12 manufacturers
Thin Layer Chromatography, Methamphetamine 12 manufacturers
Enzyme Immunoassay, Methadone 11 manufacturers
Test System, Nicotine, Cotinine, Metabolites 11 manufacturers
Test, Amphetamine, Employment And Insurance Testing, Exempt 11 manufacturers
Test, Barbiturate, Employment And Insurance Testing, Exempt 11 manufacturers
Test, Benzodiazepine, Employment And Insurance Testing, Exempt 11 manufacturers
Test, Methadone, Employment And Insurance Testing, Exempt 11 manufacturers
Enzyme Immunoassay, Propoxyphene 10 manufacturers
Gas Chromatography, Methamphetamine 10 manufacturers
Radioimmunoassay, Tricyclic Antidepressant Drugs 9 manufacturers
Test, Morphine, Employment And Insurance Testing, Exempt 8 manufacturers
Test, Propoxyphene, Employment And Insurance Testing, Exempt 7 manufacturers
Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt 7 manufacturers
Test, Methaqualone, Employment And Insurance Testing, Exempt 6 manufacturers
Test, Codeine, Employment And Insurance Testing, Exempt 4 manufacturers
Test, Morphine, Over The Counter 4 manufacturers
Thin Layer Chromatography, Morphine 4 manufacturers
Gas Chromatograph, Carbon-Monoxide 3 manufacturers
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 2 manufacturers
Enzyme Immunoassay, Nicotine And Nicotine Metabolites 2 manufacturers
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase 1 manufacturer
Calibrators, Ethyl Alcohol 1 manufacturer
Cholinesterase Test Paper 1 manufacturer
Colorimetry, Cholinesterase 1 manufacturer
Gas Chromatography, Methadone 1 manufacturer
Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep. 1 manufacturer
Reagents, Test, Tetrahydrocannabinol 1 manufacturer

Test, Opiates, Over The Counter

DrugTect Multi-Drug Test Cup

25T, FDA CLIA Waived, AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/FYL1/MDMA500/MET500/OPI300/MTD300/OXY100/TCA1000+(OXI/SG/PH)+(NIT/GLU/CRE)

Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

Prime Screen®

5-Panel T-Swab; AMP, COC, MET, OPI, THC

Enzyme Immunoassay, Amphetamine

DTX®

Catalogue number DAM-114, listed by ONE Step Detex Associates, under Enzyme Immunoassay, Amphetamine. 16 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cocaine Intercept 100 Plate Kit

Catalogue number 1122IC, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Cocaine And Cocaine Metabolites. 16 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Methadone Intercept 5 Plate Kit

Catalogue number 1142IB, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Benzodiazepine

xCupTM

The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not…

Enzyme Immunoassay, Amphetamine

Icassette™

iCassette AMP Dev(Urine) 25T

Test, Cocaine And Cocaine Metabolites, Over The Counter

Alltest Multi-Drug Rapid Urine Test Panel

25T/Box, FDA Clia Waived, MOP300/OXY100/PCP25/MET500/MDMA500/MTD300/AMP500/BAR300/BZO300/COC150/THC50/TCA1000/BUP10/FYL1

Test, Amphetamine, Over The Counter

One Step 7 Drug Multi-Panel Urine Test

5T/bag; EN/SP, OPI2000/MET500/BZO300/MDMA500/COC150/AMP500/THC50

Enzyme Immunoassay, Amphetamine

Instant-View Amphetamine Urine Dip-Strip Test

Catalogue number 03-3017, listed by Alfa Scientific Designs, Inc., United States, under Enzyme Immunoassay, Amphetamine. 16 manufacturers in China are registered for this product code.

Test, Opiates, Over The Counter

Alltest MOP300 Rapid Test Panel (Urine)

Alltest MOP300 Rapid Test Panel (Urine): 1 catalogue number listed by Hangzhou AllTest Biotech Co., Ltd., China, under Test, Opiates, Over The Counter. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

First Sign®

DOA Single Test Cup, 25Pcs/Box, CLIA Waived; First Sign for Hemosure, CLIA Waived, COC

Enzyme Immunoassay, Barbiturate

DOA 6 Panel Test

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / THC

Test, Cocaine And Cocaine Metabolites, Over The Counter

Alltest COC150 Home Rapid Test Panel (Urine)

Alltest COC150 Home Rapid Test Panel (Urine): 1 catalogue number listed by Hangzhou AllTest Biotech Co., Ltd., China, under Test, Cocaine And Cocaine Metabolites, Over The Counter. 16 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Amphetamine

Dimension® Flex® Reagent Cartridge Extc

Urine Ecstasy Screen Flex® reagent cartridge, 80 tests

Test, Methamphetamine, Over The Counter

Alltest Multi-Drug 14 Drugs Urine Test Panel

25T, CLIA WAIVED, white package MOP300/MDMA500/OXY100/PCP25/MTD300/BAR300/BZO300/AMP500/TCA1000/COC150/MET500/THC50/BUP10/FYL1+OXI/CRE/PH

Enzyme Immunoassay, Benzodiazepine

Instant-View Benzodiazepine (BZD) Urine Dip-Strip Test

Catalogue number 03-3137, listed by Alfa Scientific Designs, Inc., United States, under Enzyme Immunoassay, Benzodiazepine. 13 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Accutest Clear Methadone Drug Screen Dip & Read. CLIA-Waived 25 Tests/Kit

Catalogue number DS316, listed by Jant Pharmacal Corp., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

Architect

ARCHITECT iTheophylline Calibrators

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

AlereTM Tox Screen

Catalogue number KC990, listed by Instant Technologies, Inc., under Enzyme Immunoassay, Cocaine And Cocaine Metabolites. 16 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Opiates

Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (Fent) DT428

Fentanyl Enzyme Immunoassay

Test System, Nicotine, Cotinine, Metabolites

Amazewell

Amazewell™ D-Pen™ Mini COT Oral Fluid Test, 10T/Box

Enzyme Immunoassay, Cannabinoids

Oral Fluid Cannabinoid Enzyme Immunoassay

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay screens for cannabinoids in human oral fluid collected with the LZI Oral Fluid THC Collector. The prescription assay runs on compatible…

Thin Layer Chromatography, Methamphetamine

Chemtrue

Chemtrue® MDMA Dip Card Test, 25pcs/kit

Enzyme Immunoassay, Amphetamine

Carolina Liquid Chemistries Corp.® Amph RGT KIT Product No. DT412

AMPH (Amphetamines) 2 x 500 tests

Enzyme Immunoassay, Amphetamine

HairCheck-DT (Amphetamines)

HairCheck-DT (Amphetamines) is an ELISA test kit used for qualitative detection of amphetamines in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages:…

Enzyme Immunoassay, Methadone

Carolina Liquid Chemistries Corp.® Eddp RGT. KIT MR426

EDDP (Methadone Metabolites) 2 x 100 tests

Enzyme Immunoassay, Opiates

LZI Fentanyl (Q) Enzyme Immunoassay

The LZI Fentanyl Enzyme Immunoassay screens urine for norfentanyl, a fentanyl metabolite. When calibrated against norfentanyl, it gives a qualitative result at a cutoff of 5 nanograms per…

Enzyme Immunoassay, Opiates

Attest Drug Screen Dip Card

The Attest Drug Screen Dip Card 6AM10 screens human urine for 6-acetylmorphine at a cutoff of 10 ng/mL. It is a professional-use lateral-flow immunoassay providing a qualitative,…

Test, Opiates, Over The Counter

Alltest Multi-Drug 13 Drugs Test Cup

25T, FDA Clia, white package, MDMA500/MOP(OPI)300/OXY100/MET500/MTD300/AMP500/BAR300/BZO300/COC150/TCA1000/THC50/BUP10/FYL1+OXI/SG/PH

Enzyme Immunoassay, Cannabinoids

Synchron

Cannabinoid 20 ng Reagent (THC2 1 x 150)

Enzyme Immunoassay, Methadone

ECO™ Cup

DOA 5 in 1 Test ECO Cup, 25Pcs/Box Clia Waived BZO/COC/MTD/OPI/THC

Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

Dimension® Flex® Reagent Cartridge Pche

Pseudocholinesterase Flex® reagent cartridge, 120 tests

Enzyme Immunoassay, Opiates

ARK™ Fentanyl Assay – 500ml

The ARK™ Fentanyl Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative and determination of fentanyl in human urine at a cutoff concentration of…

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Discover Milti-Drug12 Drugs Rapid Test Cup

1T,FDA,CLIA waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/BUP10+CRE/SG/PH

Enzyme Immunoassay, Amphetamine

DRI Ecstasy Plus Assay

Catalogue number 10024631, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Amphetamine. 16 manufacturers in China are registered for this product code.

Calibrators, Ethyl Alcohol

Pointe Ethyl Alcohol Calibrator (100 Mg/dl)

Pointe Ethyl Alcohol Calibrator (100 mg/dL) 1 x 5 mL The Pointe Ethyl Alcohol Calibrators are for use as calibrators in the quantitation of the Pointe Ethyl Alcohol Reagent Set (Ref#…

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Salimetrics

High Sensitivity Salivary Cotinine Quantitative Enzyme Immunoassay Kit

Enzyme Immunoassay, Opiates

Amphetamine/Cocaine/Morphine Panel Dip

Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Opiates. 17 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Amphetamine

Instant-View Amphetamine (300) Urine Dip-Strip Test

Catalogue number 03-3019, listed by Alfa Scientific Designs, Inc., United States, under Enzyme Immunoassay, Amphetamine. 16 manufacturers in China are registered for this product code.

Test, Opiates, Over The Counter

GenaCheck™ Fentanyl Urine Home-Use Test Cassette

Catalogue number RA9-E02525, listed by Genabio Diagnostics Inc, United States, under Test, Opiates, Over The Counter. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Carolina Liquid Chemistries Corp.® Metd Methadone CC415

METD (Methadone) CX/LX/DXC 1 x 250 tests

Enzyme Immunoassay, Propoxyphene

DOA 13 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, AMP/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY/PCP/PPX/TCA/THC

Test, Opiates, Over The Counter

U-Catch

Catalogue number U-Catch PLUS Multi-Drug Test Cup, listed by Shenzhen Bioeasy Biotechnology Co., Ltd., China, under Test, Opiates, Over The Counter. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Opiates

Cedia Opiate 2k Assay

Catalogue number 100099, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Opiates. 17 manufacturers in China are registered for this product code.

Test, Methamphetamine, Over The Counter

Alltest MDMA500 Rapid Test Dipstick (Urine)

Alltest MDMA500 Rapid Test Dipstick (Urine): 1 catalogue number listed by Hangzhou AllTest Biotech Co., Ltd., China, under Test, Methamphetamine, Over The Counter. 16 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Benzodiazepine

Wondfo Drug Test Dip Card

1-Panel Card; BZO Benzodiasepines

Radioimmunoassay, Tricyclic Antidepressant Drugs

Generic

14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX

Enzyme Immunoassay, Cannabinoids

Syva® Emit® 5b3 THC Calibrator 50

Catalogue number 10445466, listed by Siemens Healthcare Diagnostics Inc, United States, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Opiates

Opiates Intercept 100 Plate Kit

Catalogue number 1150IC, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Opiates. 17 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Benzodiazepine

Alinity

Alinity c Serum Benzodiazepines Reagent Kit 400 Tests

Enzyme Immunoassay, Opiates

Rapid Diagnostics Oxycodone Test Strip KIT (50)

Oxycodone Test Strip KIT (50)

Enzyme Immunoassay, Methadone

Methadone Intercept 2 Plate Kit

Catalogue number 1142IT, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Benzodiazepine

QuickProfile™ Drugs of Abuse Panel 10 Test

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / PCP

Enzyme Immunoassay, Amphetamine

Easy@Home Multi-Drug Screen Test (15 Tests Kit)

15 tests kit; 6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO

Test, Opiates, Over The Counter

Alltest BUP10 Rapid Test Panel (Urine)-CLIA Waived

Alltest BUP10 Rapid Test Panel (Urine)-CLIA Waived: 1 catalogue number listed by Hangzhou AllTest Biotech Co., Ltd., China, under Test, Opiates, Over The Counter. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Barbiturate

Barbiturate Panel Dip

Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Barbiturate. 12 manufacturers in China are registered for this product code.

Test, Cannabinoid, Over The Counter

Atida Marijuana (THC) Drug of Abuse Rapid Urine Dip Card

25T, FDA

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cocaine OraSure 100 Plate Kit

Catalogue number 1122SC, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Cocaine And Cocaine Metabolites. 16 manufacturers in China are registered for this product code.

Test, Cannabinoid, Over The Counter

Alltest THC50 Home Rapid Test Panel (Urine)

Alltest THC50 Home Rapid Test Panel (Urine): 1 catalogue number listed by Hangzhou AllTest Biotech Co., Ltd., China, under Test, Cannabinoid, Over The Counter. 16 manufacturers in China are registered for this product code.

Test, Barbiturate, Over The Counter

Healgen (Private Label) – 1125SA3C

Healgen (DrugConfirm) - 12-panel Clicker Cup Test with Low Cutoff: AMP500/BAR300/BZO300/COC150/mAMP500/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/THC50/ Adulterants (CR/SG/OX)

Enzyme Immunoassay, Opiates

Labcorp Fentanyl Urine Visual Test

The Labcorp Fentanyl Urine Visual Test is a prescription test that detects norfentanyl, a fentanyl metabolite, in human urine. It gives a qualitative screening result at a cutoff of 5…

Gas Chromatography, Methamphetamine

Methamphetamine Intercept 100 Plate Kit

Catalogue number 1104IC, listed by Orasure Technologies, Inc., United States, under Gas Chromatography, Methamphetamine. 10 manufacturers in China are registered for this product code.

Test, Amphetamine, Over The Counter

AllTest Multi-Drug 12 Drugs Test Cup (Urine)

25T, FDA Clia Waived, MOP300/MDMA500/OXY100/COC150/MET500/MTD300/BZO300/BAR300/AMP500/TCA1000/THC50/BUP10

Enzyme Immunoassay, Benzodiazepine

Cedia Benzodiazepine Assay

3 catalogue numbers from 10016409, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Benzodiazepine. 13 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Opiates

Syva® RapidTest D.a.u.® 8

Syva® RapidTest d.a.u.® 8 THC / OPI / COC / mAMP / BZO / BAR / TCA / PCP

Test, Propoxyphene, Over The Counter

Amazewell

Amazewell™ Multi-Drug Urine Test Clicker Cup, 6-Panel, 25T/Box

Enzyme Immunoassay, Barbiturate

ECO™ Cup

DOA 5 in 1 Test ECO Cup, 25Pcs/Box Clia Waived AMP/BARB/COC/OPI/THC

Test, Methamphetamine, Employment And Insurance Testing, Exempt

HairCheck-DT Methamphetamine

HairCheck-DT (Methamphetamine) is an ELISA test kit used for qualitative detection of Methamphetamines in head hair with a cutoff 300 pg/mg of hair. Kit is comprised of 4 Component…

Enzyme Immunoassay, Cannabinoids

Maxcheck

12 Panel Rapid Multi-Drug Test Cup

Enzyme Immunoassay, Amphetamine

QuickProfile™ Drugs of Abuse Panel 7 Test

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / MTD / OPI / OXY / THC

Enzyme Immunoassay, Methadone

Twelve Panel PreScreen Plus Dip Card (Clia Waived)

Twelve Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | OXY | PCP | PPX | THC

Enzyme Immunoassay, Methadone

LZI Methadone II Enzyme Immunoassay

The LZI Methadone II Enzyme Immunoassay screens human urine for methadone at a cutoff of 300 ng/mL. It provides qualitative or semiquantitative results for prescription use on automated…

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Ethanol Assay

Catalogue number SK273-40, listed by Sekisui Diagnostics, LLC, United States, under Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method. 2 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Amphetamine

TOX/See

TOX/See Drug Screen Test AMP, BZO, COC, OPI, THC

Test, Amphetamine, Over The Counter

Alltest Multi-Drug 12 Drugs Rapid Urine Test Panel

25T, FDA CLIA WAIVED, white package, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/THC50/BUP10

Thin Layer Chromatography, Methamphetamine

Instant-View Methamphetamine (300) Urine Dip-Strip Test

Catalogue number 03-3035, listed by Alfa Scientific Designs, Inc., United States, under Thin Layer Chromatography, Methamphetamine. 12 manufacturers in China are registered for this product code.

Test, Benzodiazepine, Over The Counter