Identity
- Trade Name
- Atellica™ IM HBeAg QC FDA UDI
- Generic Name
- Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- Hepatitis Be Antigen (HBeAg) QC Kit - Atellica IM - CLT 2 x 1 x 15.0mL FDA UDI
- Model / Reference
- 10995599 FDA UDI
- Description
- Hepatitis Be Antigen (HBeAg) QC Kit - Atellica IM - CLT 2 x 1 x 15.0mL FDA UDI
Identifiers
- Catalog Number
- 10995599 FDA UDI
- Primary DI / UDI-DI
- 00630414599229 FDA UDI
- PMA Number
- P090024 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus e-antigen immunoglobulin G (IgG) 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 e-antigen immunoglobulin G (IgG) antibody IVD, control
Atellica™ IM HBeAg 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 e-antigen immunoglobulin G (IgG) antibody IVD, control.
Cleared under the same submission
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 af0c53b2-201c-47f3-8dc4-ace5ca5c6004 37 fields · synced May 29, 2026