Identity
- Trade Name
- Atellica™ IM aHBs2 QC FDA UDI
- Generic Name
- Hepatitis B virus surface total antibody IVD, control FDA UDI
- Device Name
- Anti-HBs2 (aHBs2) QC Kit - Atellica IM - CLT 2 x 2 x 10.0 mL FDA UDI
- Model / Reference
- 10995454 FDA UDI
- Description
- Anti-HBs2 (aHBs2) QC Kit - Atellica IM - CLT 2 x 2 x 10.0 mL FDA UDI
Identifiers
- Catalog Number
- 10995454 FDA UDI
- Primary DI / UDI-DI
- 00630414597843 FDA UDI
- PMA Number
- P100039 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus surface total 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
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 surface total antibody IVD, control
Atellica™ IM aHBs2 QC by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus surface total antibody IVD, control.
- VITROS — Ortho-Clinical Diagnostics · Class I
- Alinity — Abbott Ireland Diagnostics · Class II
- PreciControl Anti-HBs — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- LIAISON® XL MUREX Anti-HBs Verifiers — Diasorin Inc.
- LIAISON® XL MUREX Control Anti-HBs — Diasorin Inc.
- ADVIA Centaur® Systems aHBs2 QC — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
P100039 also covers:
- ADVIA Centaur® Systems aHBs2 MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems aHBs2 QC — Siemens Healthcare Diagnostics
- ADVIA Centaur® aHBs2 — Siemens Healthcare Diagnostics
- ADVIA Centaur® aHBs2 — Siemens Healthcare Diagnostics
- Atellica IM aHBs2 — Siemens Healthcare Diagnostics
- Atellica™ IM aHBs2 — Siemens Healthcare Diagnostics
- Atellica™ IM aHBs2 MCM — 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 b33988ab-7ce8-4a09-a590-286898700968 37 fields · synced Jun 7, 2026