Identity
- Trade Name
- co-innovation FDA UDI
- Generic Name
- Cotinine IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- COT TEST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970429843417 FDA UDI
- FDA Product Code
- MRS 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
- Not 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
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
co-innovation by Co-Innovation Biotech Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Co-Innovation Biotech Co., Ltd
Sources (1)
- FDA UDI da73fb1b-a451-4a40-90a2-085325b0b01c 33 fields · synced Jun 8, 2026