Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Cotinine IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Response Saliva Drug Test (COT) FDA UDI
- Model / Reference
- COT-2FC141 FDA UDI
- Description
- Rapid Response Saliva Drug Test (COT) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722066008376 FDA UDI
- 510(k) Number
- K223162 FDA UDI
- FDA Product Code
- MKU FDA UDI
- GMDN Term
- Cotinine IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cotinine IVD, kit, rapid ICT, clinical
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cotinine IVD, kit, rapid ICT, clinical.
- Prime Screen — WONDFO USA CO., LTD. · Class I
- U-Catch — Shenzhen Bioeasy Biotechnology Co., Ltd. · Class I
- UScreen Oral — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Areta Cotinine Test Strip(25tests one kit) — EASY HEALTHCARE CORPORATION · Class I
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class I
- U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) — Eterbio, Inc. · Class I
- U-Catch — Shenzhen Bioeasy Biotechnology Co., Ltd. · Class I
- UScreen Oral — Guangzhou Decheng Biotechnology Co., LTD · Class II
Cleared under the same submission
K223162 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI 48e368b0-55ea-4c54-80db-a8c87b4419f1 34 fields · synced Jun 1, 2026