Aimstep Cotinine
Cassette test for nicotine
11manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Germaine Laboratories, Inc., United States |
|---|---|
| FDA product code | MRS |
| Device type | Test System, Nicotine, Cotinine, Metabolites |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3220 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-05-12 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 40010 | In distribution | ||
| 40015 | 50 | In distribution | |
| 40012 | 2,000 | 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 |
| 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 |
| FirstCheck Cotinine Oral Fluid Test | Hangzhou AllTest Biotech Co., Ltd. | 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.