Enzyme Immunoassay, Cannabinoids

Which Manufacturers in China Make This?

18 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Guangdong and Beijing, and 3 other provinces. 6 of them are contract manufacturers, able to build to a buyer’s own specification.

Abon Biopharm (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Assure Tech. (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
Co-Innovation Biotech Co., Ltd. Guangdong, contract manufacturer
Core Technology Co., Ltd. Beijing, contract manufacturer
Eterbio, Inc. Guangdong
Guangzhou Wondfo Biotech Co., Ltd. Guangdong, contract manufacturer
Guangzhou Decheng Biotechnology Co., Ltd. Guangdong
Hangzhou Clongene Biotech Co., Ltd. Zhejiang
Hangzhou Laihe Biotech Co., Ltd. Zhejiang, contract manufacturer
Hongkong Conlight Medical Group Limited Hong Kong
Hangzhou AllTest Biotech Co., Ltd. Zhejiang, contract manufacturer
Hangzhou Biotest Biotech Co., Ltd. Zhejiang, contract manufacturer
Nantong Egens Biotechnology Co., Ltd. Jiangsu
Prometheus Bio Inc. Zhejiang, contract manufacturer
Safecare Biotech(Hangzhou)Co., Ltd. Zhejiang
W.h.p.m. Bioresearch & Technology Co., Ltd. Beijing
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

How Is LDJ Classified?

Enzyme Immunoassay, Cannabinoids is FDA product code LDJ, Class 2, 21 CFR 862.3870.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 5 clearances under this code; the FDA took a median of 81 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 15 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Process control (7), Nonconforming Material/Component (3) and Storage (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Enzyme Immunoassay, Cannabinoids

Six Panel PreScreen Plus Cup With Adulterants (Clia Waived)

Six Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC +AD

Enzyme Immunoassay, Cannabinoids

Prime Screen

PRIME SCREEN® Marijuana (THC) Urine Test Strip, 20 Tests per Box with Plastic Urine Cups

Enzyme Immunoassay, Cannabinoids

Accutest MultiDrug Test Cup 6+3 W. Adulteration Screen

MultiDrug Test Cup 6+3 w. Adulteration Screen (pH/ S.G./ Oxidant) (AMP1000 /COC 300 /MET 1000/ OPI 2000/ PCP 25/ THC 50)

Enzyme Immunoassay, Cannabinoids

Easy@Home Marijuana Test Cup(1 Test Kit)

Easy@Home Marijuana Test Cup(ECTH4-114A3)

Enzyme Immunoassay, Cannabinoids

Fastest Labs

FASTEST 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box

Enzyme Immunoassay, Cannabinoids

Cibio Test

12P Rapid Multi-Drug Test Cup

Enzyme Immunoassay, Cannabinoids

QuikStrip Multidrug Screening Dip Card Test

QuikStrip Multidrug 5 Test, AMP 500, COC 300, MET 500, OP I 2000, THC 50

Enzyme Immunoassay, Cannabinoids

DOA 3 Panel Test

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / OPI / THC

Enzyme Immunoassay, Cannabinoids

Cannabinoids Intercept 100 Plate Kit

Catalogue number 1118IC, listed by Orasure Technologies, Inc., United States, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

Five Panel Pre Screen Plus Dip Card (Clia Waived)

Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC

Enzyme Immunoassay, Cannabinoids

Ecoii

DOA 10 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC/PH-SG-OX/CR-NI-GL

Enzyme Immunoassay, Cannabinoids

Areta MarijuanaTest Strip -THC(15 Tests Kit)

15 tests per kit;THC Single Panel

Enzyme Immunoassay, Cannabinoids

DrugSmart Cup 6

DrugSmart Cup 6, AMP/BZO/COC/MET/OPI2K/THC, 25 tests/kit

Enzyme Immunoassay, Cannabinoids

Cedia Multi-Level THC

Catalogue number 1661256, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

Preknow Multi-Drug (AMP/BZO/COC/OPI/THC) Screen Test (5 Dipcards)

5 tests kit; 5-Panel Dip Cards; AMP/BZO/COC/OPI/THC

Enzyme Immunoassay, Cannabinoids

DOA 1 Panel Test

Immunoassay for the detection of the following drug substance(s) in human urine: THC

Enzyme Immunoassay, Cannabinoids

Marijuana Strip

Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

QuickProfile™ Drugs of Abuse Panel 2 Test

Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC

Enzyme Immunoassay, Cannabinoids

Easy@Home TRA Single Drug Screen Test (25 Tests Kit)

Catalogue number EDTR-114, listed by Easy Healthcare Corporation, United States, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

T-Cup® Compact

T-Cup® Compact Multi-Drug Urine Test Cup

Enzyme Immunoassay, Cannabinoids

Number 1

12-Panel Drug Test Cup: AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, PCP, TCA, THC

Enzyme Immunoassay, Cannabinoids

Eight Panel PreScreen Plus Dip Card (Clia Waived)

Eight Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | MOR | MTD | OXY | THC

Enzyme Immunoassay, Cannabinoids

AlereTM Tox Screen

Catalogue number KC840A, listed by Instant Technologies, Inc., under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

Marijuana Test Strip

Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

Carolina Liquid Chemistries Corp.® THC RGT KIT Product No. DT410

THC (Cannabinoid) 50 ng/mL 2 x 500 tests

Enzyme Immunoassay, Cannabinoids

THC Test Strip

Catalogue number THC3.5, listed by Co-Innovation Biotech Co., Ltd., China, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

Easy@Home THC Single Drug Screen Test (10 Tests Kit)

Catalogue number EDTH-114-10, listed by Easy Healthcare Corporation, United States, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

Alere Icup Dx

Drugs of Abuse Test Cup for detection of (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with adulteration tests Cr, Ni, pH, Bl, S.G., CLIA Waived

Enzyme Immunoassay, Cannabinoids

Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)

15 THC test dip-cards

Enzyme Immunoassay, Cannabinoids

Quick Test

Individual 10-panel drug test cassette

Enzyme Immunoassay, Cannabinoids

Safecup III Multidrug N5

Catalogue number 45485, listed by Germaine Laboratories, Inc., United States, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

Atellica CH Thc

Cannabinoids (Thc) Atellica CH - RGT 1520T

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…

Enzyme Immunoassay, Cannabinoids

Synchron

Cannabinoid 20 ng Reagent (THC2 1 x 150)

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, Cannabinoids

Maxcheck

12 Panel Rapid Multi-Drug Test Cup

Enzyme Immunoassay, Cannabinoids

Easy@Home THC Single Drug Screen Test (6 Tests Kit)

6 tests kit;THC Single Panel

Enzyme Immunoassay, Cannabinoids

QuickProfile™ Drugs of Abuse Panel 5 Test

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI-2000 / THC

Enzyme Immunoassay, Cannabinoids

Statcup® II

STAT II DOA 14 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC/PH-CR-OX

Enzyme Immunoassay, Cannabinoids

Aimscreen THC

Lateral flow immunoassay for the detection of Marijuana (THC) in urine.

Enzyme Immunoassay, Cannabinoids

CSI

CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, CLICK SEAL CAP, AMP, BAR, BUP, BZO, COC, MET, MDMA, OPI, MTD, OXY, PCP, PPX, TCA, THC, 25/BX

Enzyme Immunoassay, Cannabinoids

Escreen Ecup

The eScreen eCup® is a patented urine collection device designed to allow for rapid, under-seal screening. The eCup’s lid contains several embedded reagent test strips that are sensitive to…

Enzyme Immunoassay, Cannabinoids

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 / PCP / THC

Enzyme Immunoassay, Cannabinoids

Methamphetamine/Phencyclidine/Marijuana Panel Dip

Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Cannabinoids. 18 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Cannabinoids

REF

SMC PRIVATE LABEL Multi-Panel Drug Test Cup, 6 Panel, CLIA Waived, Click Seal Cap, AMP, BZO, COC, mAMP, OPI, THC, 25/BX

Enzyme Immunoassay, Cannabinoids

Atellica CH Cannabinoids (ThcC)

Cannabinoids (ThcC) Atellica CH - RGT 380T

Enzyme Immunoassay, Cannabinoids

AccuSign® THC Card

AccuSign® THC card; 35 Test kit; CE

Enzyme Immunoassay, Cannabinoids

Construction

One Step Drug Screen Test Card (COC300/AMP1000/mAMP1000/THC50/MTD300/MDMA500/OPI2000/OXY100/PPX300/PCP25/BAR300/BZO300)

Enzyme Immunoassay, Cannabinoids

Dimension Vista® Flex® Reagent Cartridge THC

Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer