Enzyme Immunoassay, Methadone

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Zhejiang, Guangdong and Beijing, and 2 other provinces: 11 hold an FDA registration. 4 are contract manufacturers.

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
Guangzhou Decheng Biotechnology Co., Ltd. Guangdong
Hongkong Conlight Medical Group Limited Hong Kong
Hangzhou AllTest Biotech Co., Ltd. Zhejiang, contract manufacturer
Hangzhou Biotest Biotech Co., Ltd. Zhejiang, contract manufacturer
Prometheus Bio Inc. Zhejiang, contract manufacturer
W.h.p.m. Bioresearch & Technology Co., Ltd. Beijing
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

What Is FDA Product Code DJR?

Enzyme Immunoassay, Methadone is FDA product code DJR, Class 2, 21 CFR 862.3620.

What Does It Take to Sell It in the United States?

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 1 clearance under this code; the FDA took 75 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Process control (1) and Error in labeling (1).

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

Enzyme Immunoassay, Methadone

Atellica CH Methadone (MdnC)

Methadone (MdnC) Atellica CH - RGT 380T

Enzyme Immunoassay, Methadone

Icup™

Catalogue number DUA-1107-093, listed by Instant Technologies, Inc., under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Architect

Methadone

Enzyme Immunoassay, Methadone

Buprenorphine/Methadone Panel Dip

Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Reditest®

Panel 1 Methadone (MTD)

Enzyme Immunoassay, Methadone

Safecup III Multidrug 12

Catalogue number 41513, listed by Germaine Laboratories, Inc., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Monitect Drug Screen Cassette Test

MTD300 Cassette Tests

Enzyme Immunoassay, Methadone

Buprenorphine/Methadone Turnkey Split Cup

Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

DOA 1 Panel Test

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

Enzyme Immunoassay, Methadone

Rapid Diagnostics Methadone Test Strip

Methadone Test Strip

Enzyme Immunoassay, Methadone

U-Card Drug Test Screen

12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC with Adulteration strip(S.G./CRE/ pH)

Enzyme Immunoassay, Methadone

Alere Icup Dx

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

Enzyme Immunoassay, Methadone

DrugSmart Cup 14

DrugSmart Cup 14 CLIA-Waived, AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/PPX/TCA/THC, 25tests/kit

Enzyme Immunoassay, Methadone

Easy@Home Multi-Drug Screen Test (5 Tests/kit)

5 tests per kit;10-Panel Dip Card; AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA

Enzyme Immunoassay, Methadone

U-Ucptm Drug Test Screen 12 Panel Drug Test Cup

U-UCPTM Drug Test Screen 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)

Enzyme Immunoassay, Methadone

U-Cup

10 Panel Drug Test Cup BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC with Adulteration strip(S.G.,CRE, pH)

Enzyme Immunoassay, Methadone

Pointe Methadone Metabolite (Eddp) Reagent Set

Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Metabolite (EDDP) Reagent Set is an in vitro diagnostic test intended for the qualitative…

Enzyme Immunoassay, Methadone

Buprenorphine/Methadone Quick Cup

Catalogue number 1.0, listed by Assure Tech. (Hangzhou) Co., Ltd., China, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Carolina Liquid Chemistries Corp.® Metd RGT. KIT AU-415

METD (Methadone)

Enzyme Immunoassay, Methadone

ARK™ Eddp Assay – 500ml

The ARK EDDP Assay is a prescription laboratory test for detecting EDDP in human urine with an automated clinical chemistry analyzer. It provides qualitative or semiquantitative results…

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, 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.

Enzyme Immunoassay, Methadone

Carolina Liquid Chemistries Corp.® Eddp RGT. KIT MR426

EDDP (Methadone Metabolites) 2 x 100 tests

Enzyme Immunoassay, Methadone

ECO™ Cup

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

Enzyme Immunoassay, Methadone

Carolina Liquid Chemistries Corp.® Metd Methadone CC415

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

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, 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…

Enzyme Immunoassay, Methadone

Safecup II Multidrug 10

Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, mAMP, THC, MTD, OPI, PCP, BAR, BZO, MDMA (cocaine,…

Enzyme Immunoassay, Methadone

Methadone Intercept 100 Plate Kit

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

Enzyme Immunoassay, Methadone

Methadone Enzyme Immunoassay

2 catalogue numbers from 0111, listed by LIN-ZHI International, Inc., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Instant-View Methadone Urine Dip Cassette Test

Catalogue number 03-3172QW, listed by Alfa Scientific Designs, Inc., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Safecup III Multidrug 10

Catalogue number 40105, listed by Germaine Laboratories, Inc., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

OralTox

OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC

Enzyme Immunoassay, Methadone

Ten Panel Clear Scan Drug Test Cup

Ten Panel Clear Scan Drug Test Cup Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP

Enzyme Immunoassay, Methadone

Advia® Chemistry Metmtb Methadone Metabolite Reagents

TBD

Enzyme Immunoassay, Methadone

Fastect II Drug Screen Dipstick Test

BZO300/COC300/OPI300/MTD300 multiple drugs dipstick test

Enzyme Immunoassay, Methadone

Cedia DAU Methadone

Catalogue number 1730916, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

Alere Icup DX Pro

Alere iCup DX Pro Integrated CLIA Waived Urine Drug Screening Device THC50, COC300, OPI300, AMP1000, MET1000, BZO300, MTD300, OXY100 with (Cr,S.G.,pH)

Enzyme Immunoassay, Methadone

CSI

CSI Cup - CLIA Screen In-Vitro 14 Panel + 3 AD Drug Test, CLICK SEAL CAP, AMP, BAR, BUP, BZO, COC, MET, MDMA, OPI, MTD, OXY, PCP, PPX, TCA, THC, + OX, PH, SG,

Enzyme Immunoassay, Methadone

Instant-View Multi-Drugs of Abuse Urine Test AMP, BUP, MET, MOR300, MTD

Catalogue number 03-3519, listed by Alfa Scientific Designs, Inc., United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

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

15 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA

Enzyme Immunoassay, Methadone

Safecup II Multidrug 12

Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, mAMP, THC, MTD, MDMA, OXY, OPI, PCP, BAR, BZO, TCA

Enzyme Immunoassay, Methadone

Easy@Home Multi-Drug Screen Test (2 Tests Kit)

2 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA

Enzyme Immunoassay, Methadone

PreChek

12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300•BUP10)

Enzyme Immunoassay, Methadone

Cedia Methadone Metabolite (Eddp) Assay

2 catalogue numbers from 100096, listed by Microgenics Corporation, United States, under Enzyme Immunoassay, Methadone. 11 manufacturers in China are registered for this product code.

Enzyme Immunoassay, Methadone

DrugSmart Cup 10

DrugSmart Cup 10, AMP/BAR/BZO/COC150/MDMA/MET500/OPI300/OXY/PCP/THC+ Adulterant Panel, 25tests/kit

Enzyme Immunoassay, Methadone

QuikStrip MultiDrug X Screening Dip Card

QuikStrip Multidrug 1 Screening Dip Card Test - MAD 300 ng/ml

Enzyme Immunoassay, Methadone

Carolina Liquid Chemistries Corp.® Metd RGT KIT Product No. DT415

METD (Methadone) 2 x 500 tests

Enzyme Immunoassay, Methadone

Ten Panel PreScreen Plus Cup (Clia Waived)

Ten Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: THC | COC | OPI | mAMP | AMP | BZO | MTD | OXY | MDMA | BUP

Enzyme Immunoassay, Methadone

ARK™ Eddp Assay – 115ml

The ARK EDDP Assay screens human urine for EDDP using an automated clinical chemistry analyser. It provides qualitative or semiquantitative results at cutoff concentrations of 100 ng/mL and…

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