Identity
- Trade Name
- Acetaminophen FDA UDI
- Generic Name
- Acetaminophen IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 20767174160 FDA UDI
Identifiers
- Catalog Number
- 20767174160 FDA UDI
- Primary DI / UDI-DI
- 04015630946372 FDA UDI
- 510(k) Number
- K110726 FDA UDI
- FDA Product Code
- LDP FDA UDI
- GMDN Term
- Acetaminophen IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3030 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
No
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
Acetaminophen by Roche Diagnostics Corp. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 13b7efdb-6a70-47b6-8434-44975bc68c9f 36 fields · synced Jun 1, 2026