Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Device Name
- ARCHITECT CORE-M Controls FDA UDI
- Model / Reference
- 6L23-10 FDA UDI
- Description
- ARCHITECT CORE-M Controls FDA UDI
Identifiers
- Catalog Number
- 06L2310 FDA UDI
- Primary DI / UDI-DI
- 00380740011147 FDA UDI
- PMA Number
- P060035 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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 immunoglobulin M (IgM) antibody IVD, control
Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MONOLISA™ — Bio-Rad Laboratories · Class II
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
- Abbott
Sources (1)
- FDA UDI fc81249c-e3e0-4127-8cf8-cf3518036722 37 fields · synced Jun 7, 2026