Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Hepatitis B virus surface antigen IVD, control FDA UDI
- Device Name
- Alinity i HBsAg Qualitative II Controls FDA UDI
- Model / Reference
- 08P1012 FDA UDI
- Description
- Alinity i HBsAg Qualitative II Controls FDA UDI
Identifiers
- Catalog Number
- 08P1012 FDA UDI
- Primary DI / UDI-DI
- 00380740146245 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Alinity by Abbott Ireland Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus surface antigen IVD, control.
- PreciControl HBsAg II Auto Confirm — Roche Diagnostics Corp.
- PreciControl HBsAg II — Roche Diagnostics Corp. · U
- PreciControl HBsAg II — Roche Diagnostics Corp. · Class II
- LIAISON XL MUREX Control HBsAg Qual — Diasorin S.P.A
- ADVIA Centaur® Systems HBsAg QC — Siemens Healthcare Diagnostics · Class II
- Atellica™ IM HBsII QC — Siemens Healthcare Diagnostics · Class II
- Hepatitis B Virus Surface Antigen Control Slides — BIO SB, INC. · Class I
- Hepatitis B Virus Surface Antigen control slides — BIO SB, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI 841cb285-ecb4-48f5-9c3d-fc89f57345b9 36 fields · synced May 31, 2026