Identity
- Trade Name
- co-innovation FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- OPI Test Strip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970429840423 FDA UDI
- FDA Product Code
- PVH FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 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 II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Co-Innovation Biotech Co., Ltd
Sources (1)
- FDA UDI e16531a9-608a-4d45-850a-9150eb1ee501 33 fields · synced May 31, 2026