FirstCheck Cotinine Oral Fluid Test
ABTDCTCUBO0101, 1T/kit, COT20
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (4), Beijing (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Hangzhou AllTest Biotech Co., Ltd., China |
|---|---|
| FDA product code | MRS |
| Device type | Test System, Nicotine, Cotinine, Metabolites |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3220 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2025-02-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exploro Highly Sensitive Nicotine Urine Test | Safecare Biotech(Hangzhou)Co., Ltd. | 4 |
| T Testahead Cotinine(COT) Urine Test Dipcard | Safecare Biotech(Hangzhou)Co., Ltd. | 3 |
| Aimstep Cotinine | Germaine Laboratories, Inc. | 3 |
| U-Catch | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2 |
| U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) | Eterbio, Inc. | 2 |
| Firstview COT Urine Dip Card Test | Safecare Biotech(Hangzhou)Co., Ltd. | 2 |
| iCassette™ | Instant Technologies, Inc. | 1 |
| Cotinine Elisa | DRG International, Inc. | 1 |
| Prime Screen | Wondfo USA Co., Ltd. | 1 |
| Areta Cotinine Test Strip(25tests one kit) | Easy Healthcare Corporation | 1 |
| Easy@Home Nicotine Urine Test (5 tests one kit) | Easy Healthcare Corporation | 1 |
| Cotinine Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
Showing 12 of 32. All products under Test System, Nicotine, Cotinine, Metabolites
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.