Identity
- Trade Name
- Atellica™ IM HBsII Confirmatory FDA UDI
- Generic Name
- Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T FDA UDI
- Model / Reference
- 10995603 FDA UDI
- Description
- HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T FDA UDI
Identifiers
- Catalog Number
- 10995603 FDA UDI
- Primary DI / UDI-DI
- 00630414599267 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus surface antigen neutralization 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 surface antigen neutralization IVD, kit, chemiluminescent immunoassay
Atellica™ IM HBsII Confirmatory 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 antigen neutralization IVD, kit, chemiluminescent immunoassay.
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 7689f5c7-9144-4269-a552-2c4c0152b483 36 fields · synced May 30, 2026