Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Hepatitis B virus surface antigen IVD, control FDA UDI
- Device Name
- Alinity s HBsAg Release Control Kit FDA UDI
- Model / Reference
- 06P0215 FDA UDI
- Description
- Alinity s HBsAg Release Control Kit FDA UDI
Identifiers
- Catalog Number
- 06P0215 FDA UDI
- Primary DI / UDI-DI
- 00380740136802 FDA UDI
- GMDN Term
- Hepatitis B virus surface antigen IVD, control FDA UDI
Classification
- 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
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 — 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.
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- 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI 8c571a4a-510a-44b2-a93e-0d705c808d22 36 fields · synced Jun 8, 2026