Identity
- Trade Name
- MONOLISA™ FDA UDI
- Generic Name
- Hepatitis B virus core antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- MONOLISA™ Anti-HBc EIA 192 Tests FDA UDI
- Model / Reference
- 26186 FDA UDI
- Description
- MONOLISA™ Anti-HBc EIA 192 Tests FDA UDI
Identifiers
- Catalog Number
- 26186 FDA UDI
- Primary DI / UDI-DI
- 00847865011372 FDA UDI
- PMA Number
- P060031 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus core antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3172 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
No
FDA UDI
Convenience Kit
Yes
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: Hepatitis B virus core antigen IVD, kit, enzyme immunoassay (EIA)
Monolisa™ by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 14614b9b-9da7-42dc-a82a-4ca000ea1f3c 38 fields · synced Jun 8, 2026