Identity
- Trade Name
- Atellica™ IM HBsII QC FDA UDI
- Generic Name
- Hepatitis B virus surface antigen IVD, control FDA UDI
- Device Name
- HBsAgII (HBsII) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL FDA UDI
- Model / Reference
- 10995605 FDA UDI
- Description
- HBsAgII (HBsII) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL FDA UDI
Identifiers
- Catalog Number
- 10995605 FDA UDI
- Primary DI / UDI-DI
- 00630414599281 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus surface antigen 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 antigen IVD, control
Atellica™ IM HBsII QC by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hepatitis B virus surface antigen IVD, control.
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- Alinity — Abbott Ireland Diagnostics
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- LIAISON XL MUREX Control HBsAg Qual — Diasorin S.P.A
- ARCHITECT — Abbott Ireland Diagnostics · Class II
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 cf06c9a3-debc-42d4-8a52-97dfda1212cd 36 fields · synced May 29, 2026