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Hepatitis B Virus Surface Antigen Control Slides
FDA UDIClass I (US FDA UDI)
by Bio Sb, Inc.
Identity
- Trade Name
- Hepatitis B Virus Surface Antigen Control Slides FDA UDI
- Generic Name
- Hepatitis B virus surface antigen IVD, control FDA UDI
- Device Name
- Hepatitis B Virus Surface Antigen Control Slides FDA UDI
- Model / Reference
- BSB-9208-CS FDA UDI
- Description
- Hepatitis B Virus Surface Antigen Control Slides FDA UDI
Identifiers
- Catalog Number
- BSB-9208-CS FDA UDI
- Primary DI / UDI-DI
- B502BSB9208CS0 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Hepatitis B virus surface antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
Yes
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
Hepatitis B Virus Surface Antigen Control Slides by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI 92417f39-6d8d-425e-9e48-508ec6dfe954 36 fields · synced May 30, 2026