Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ARCHITECT HAVAB-M Reagent Kit FDA UDI
- Model / Reference
- 6L21-25 FDA UDI
- Description
- ARCHITECT HAVAB-M Reagent Kit FDA UDI
Identifiers
- Catalog Number
- 06L2125 FDA UDI
- Primary DI / UDI-DI
- 00380740011093 FDA UDI
- 510(k) Number
- K063329 FDA UDI
- FDA Product Code
- LOL FDA UDI
- GMDN Term
- Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3310 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 A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.
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- Elecsys Anti-HAV II — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Elecsys AntiHAV IgM — Roche Diagnostics Corp. · Class II
- Atellica IM aHAVM — Siemens Healthcare Diagnostics · 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 e9712e8a-6af2-4a45-a02c-589f2e26c958 37 fields · synced May 30, 2026