Atellica™ IM HBsII
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Atellica IM Hepatitis B surface Antigen II (HBsII) EUDAMEDAtellica™ IM HBsII FDA UDI
- Generic Name
- Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_D_KIT_HBsAgII EUDAMEDHBsAgII (HBsII) - Atellica IM - RGT - 200T FDA UDI
- Model / Reference
- 10995604 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_D_KIT_HBsAgII EUDAMED
- Description
- HBsAgII (HBsII) - Atellica IM - RGT - 200T FDA UDI
Identifiers
- Catalog Number
- 10995604 FDA UDI
- Primary DI / UDI-DI
- 00630414599274 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901882WE EUDAMED
- PMA Number
- P110041 FDA UDI
- FDA Product Code
- LOM FDA UDI
- EMDN Code
- W0105020201 HEPATITIS B SURFACE ANTIGEN EUDAMED
- GMDN Term
- Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class D EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3172 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Atellica™ IM HBsII by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay.
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
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- Alinity — Abbott Ireland Diagnostics
- Alinity — Abbott Ireland Diagnostics · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
Cleared under the same submission
P110041 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI d77e9037-9ee2-43e4-8b80-ef71b90f94a9 37 fields · synced Sep 17, 2026
- EUDAMED 6bbcc891-92bb-4dae-b465-7a6d03364d39 61 fields · synced Sep 17, 2026