Identity
- Trade Name
- Atellica™ IM aHBcM FDA UDI
- Generic Name
- Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- HBc IgM (aHBcM) - Atellica IM - RGT - 100T FDA UDI
- Model / Reference
- 10995449 FDA UDI
- Description
- HBc IgM (aHBcM) - Atellica IM - RGT - 100T FDA UDI
Identifiers
- Catalog Number
- 10995449 FDA UDI
- Primary DI / UDI-DI
- 00630414597799 FDA UDI
- PMA Number
- P030040 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay 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
No
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
Category: Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Atellica™ IM aHBcM by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.
- LIAISON XL MUREX HBcIgM — Diasorin Inc.
- Elecsys Anti-HBc IgM — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott · Class II
- Alinity — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Elecsys Anti-HBc IgM — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
Cleared under the same submission
P030040 also covers:
- IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- ADVIA Centaur® HBc IgM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems HBc IgM QC — Siemens Healthcare Diagnostics
- Atellica IM aHBcM — Siemens Healthcare Diagnostics
- Atellica™ IM aHBcM QC — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 40c7e969-344f-4d7a-a5b4-7642bc02cb4b 37 fields · synced May 30, 2026