Co-Innovation Biotech Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 29 device types, 29 products catalogued, 10 clearances.
Co-Innovation Biotech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Methadone and 27 other device types. 27 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
29device types registered with the FDA
29products catalogued under its own name
10510(k) clearances
Registration
| Registered name | CO-INNOVATION BIOTECH CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010220539 |
| FEI number | 3010220539 |
| DUNS | 421302978 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 广州合尔拓生物科技有限公司 |
|---|---|
| Unified social credit code | 91440106591544869L |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | No. 9 Baihe 3 street, Economic and Technological Development East Zone, |
| Postal code | 510530 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test, Cannabinoid (THC) Test System, Easy@Home Marijuana Test Strip (THC 20),ESTH-215 | 2016 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 11 |
| Enzyme Immunoassay, Opiates | Class 2 | Rapid Fentanyl (FYL) Test Strip ,Rapid Fentanyl (FYL) Test Dipcard, Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 16 |
| Enzyme Immunoassay, Propoxyphene | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 10 |
| Gas Chromatography, Methamphetamine | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 10 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | Co-innovation, CheckYo Pregnancy&Ovulation Combo Test Kit, CheckYo Pregnancy Test Midstream, Areta Pregnancy Test Strip, CheckYo Pregnancy Test Strip | 2022 | 30 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | Areta Ovulation Test Kit, CheckYo Ovulation Test Strip, Areta Ovulation Test Strip | 2013 | 16 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 9 |
| Test System, Nicotine, Cotinine, Metabolites | Class 1 | Rapid COT Test | 2021 | 11 |
| Test, Amphetamine, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 16 |
| Test, Barbiturate, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 16 |
| Test, Benzodiazepine, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 16 |
| Test, Cannabinoid, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | FSH Menopause Test | 2026 | 30 |
| Test, Methadone, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 17 |
| Test, Methamphetamine, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 16 |
| Test, Morphine, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 4 |
| Test, Opiates, Over The Counter | Class 2 | Rapid Urine Fentanyl ( FYL ) Test Strip ,Rapid Urine Fentanyl ( FYL ) Test Dipcard, U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 12 |
| Test, Propoxyphene, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) | 2024 | 16 |
| Thin Layer Chromatography, Methamphetamine | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 12 |
| Thin Layer Chromatography, Morphine | Class 2 | Co-innovation, ACCU KNOW Urine Drug Test | 2016 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| co-innovation | LDJ | 8 |
| co-innovation | DJG | 4 |
| co-innovation | DKZ | 3 |
| Co-innovation | LCX | 3 |
| Aicare | LDJ | 2 |
| co-innovation | DJZ | 1 |
| co-innovation | DIC | 1 |
| HealthyWiser | LCX | 1 |
| co-innovation | NGL | 1 |
| Dtpm | DIS | 1 |
| Cibio Test | LFG | 1 |
| Qtest | LDJ | 1 |
| co-innovation | DIO | 1 |
| co-innovation | JXN | 1 |
| co-innovation | JXM | 1 |
| Flo | CEP | 1 |
| MomMed | LCX | 1 |
| co-innovation | PVH | 1 |
| HCG Test Strip | LCX | 1 |
| Pregable | LCX | 1 |
| Flo | LCX | 1 |
| co-innovation | MRS | 1 |
| Dtpm | DJC | 1 |
| THC Test Strip | LDJ | 1 |
| co-innovation | CEP | 1 |
| Aicare | LCX | 1 |
| Cibio Test | LDJ | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241100 | 2024-05-22 | NGL | Traditional | This company |
| K231904 | 2024-03-08 | DJG | Traditional | This company |
| K232732 | 2024-01-17 | LDJ | Traditional | This company |
| K213808 | 2022-04-05 | LCX | Special | This company |
| K153050 | 2016-04-26 | DJG | Special | This company |
| K142800 | 2014-12-11 | DKZ | Traditional | This company |
| K140748 | 2014-08-20 | DJG | Traditional | This company |
| K140215 | 2014-06-16 | DIS | Traditional | This company |
| K131110 | 2014-01-15 | DKZ | Traditional | This company |
| K132085 | 2013-11-12 | LCX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Pregnancy tests, Ovulation tests, Drug of abuse tests, Fentanyl test strips, Xylazine test strips |
| Certifications | CE, FDA 510(k), CLIA waived, ISO 13485, UK MHRA, SGS QIP |
| Export markets | US, UK, EU |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.