Chemtron Biotech, Inc.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3008852306

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008852306
FEI Number
3008852306
Entity Name
Chemtron Biotech, Inc.
City/State/Country
San Diego, CA, US
Establishment Address
9245 Brown Deer Rd Ste B, San Diego, CA 92121, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Chemtron Biotech, Inc. (Owner Number: 10035407)
Owner / Operator Contact Address
9245 Brown Deer Road, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Chemtrue® Multi-Panel Drug Screen Cup Tests Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test Chemtrue® Multi-Panel Drug Screen Dip Card Tests Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test Chemtrue Drug Screen Cup Tests Chemtrue Multi-Panel Drug Screen Tests Chemtrue hCG Pregnancy Urine Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PVG Test, Morphine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3640 2022-03-01
DNK Thin Layer Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2024-01-05
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2024-01-05
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2024-01-05
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2024-01-05
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2024-01-05
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2024-01-05
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2024-01-05
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2024-01-05
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2024-01-05
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2024-01-05
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2024-01-05
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2024-01-05
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2024-01-05
PUY Test, Barbiturate, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3150 2022-03-01
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2022-03-01
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2022-03-01
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2015-07-14
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2015-07-14
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2015-07-14
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2015-07-14
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2015-07-14
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2015-07-14
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2015-07-14
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2015-07-14
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2015-07-14
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2015-07-14
DNK Thin Layer Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2015-07-14
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2015-07-14
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2022-03-01
LGF Component, Cast Orthopedic Class 1 888.5940 2015-07-14
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2015-07-14
PVE Test, Methadone, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3620 2022-03-01
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2015-07-14
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2022-03-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Chemtron Biotech, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150602 Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Morphine - Methamphetamine 2015-04-07
K131232 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) 2013-05-31
K112395 Guangzhou Wondfo Biotech Co., Ltd. WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST 2011-09-09
K142609 Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine 2014-12-18
K833577 Syva Co. MODIF. OF EMIT URINE BARBITURATE 1984-01-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2013 Alere San Diego, Inc. 2
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-2787-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2788-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2789-2018 Guangzhou Wondfo Biotech Co., Ltd. 2
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-0006-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008852306. Last updated year: 2026. Please use registration number 3008852306 when referencing this establishment in official correspondence.
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