Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010220539

FEI Number

3010220539

Entity Name

CO-INNOVATION BIOTECH CO.,LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No. 9 Baihe 3 street, Economic and Technological Development East Zone,, Guangzhou Guangdong 510530, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Co-Innovation Biotech Co.,Ltd. (Owner Number: 10042828)

Owner / Operator Contact Address

No. 9 Baihe 3 street,Economic and, Technological Development East Zone,, Guangzhou, CN-GD 510530, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rapid Fentanyl (FYL) Test Strip ,Rapid Fentanyl (FYL) Test Dipcard U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) CheckYo Ovulation Test Strip Areta Ovulation Test Strip Areta Ovulation Test Kit Co-innovation ACCU KNOW Urine Drug Test Cannabinoid (THC) Test System Easy@Home Marijuana Test Strip (THC 20),ESTH-215 Rapid Urine Fentanyl ( FYL ) Test Strip ,Rapid Urine Fentanyl ( FYL ) Test Dipcard Co-innovation CheckYo Pregnancy Test Midstream Areta Pregnancy Test Strip CheckYo Pregnancy&Ovulation Combo Test Kit CheckYo Pregnancy Test Strip FSH Menopause Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-03-11
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-12-17
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-12-17
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-12-17
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-12-17
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-12-17
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-12-17
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-12-17
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-12-17
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-12-17
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-12-17
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2024-12-17
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-12-17
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2013-01-03
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2016-05-03
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2016-05-03
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2016-05-03
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2016-05-03
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2016-05-03
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-05-03
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2016-05-03
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2016-05-03
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-05-03
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2016-05-03
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2016-05-03
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2016-05-03
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2016-05-03
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-01-19
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-05-23
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-04-06
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2026-06-03

Official Correspondent

Hong Feng

US Agent Details

Jason Zhou Email: ShamrockIE49@hotmail.com Phone: (626) 6325067

Related Public Records

Same Entity

Co-Innovation Biotech Co.,Ltd.

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
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01
K150179	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids	2015-02-25
K112310	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHADONE URINE TEST,OPIATE TEST	2011-09-08
K093175	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. 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 3010220539. Last updated year: 2026. Please use registration number 3010220539 when referencing this establishment in official correspondence.