Identity
- Trade Name
- Alinity m FDA UDI
- Generic Name
- HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Alinity m HIV-1 AMP Kit FDA UDI
- Model / Reference
- 08N45-095 FDA UDI
- Description
- Alinity m HIV-1 AMP Kit FDA UDI
Identifiers
- Catalog Number
- 08N45-095 FDA UDI
- Primary DI / UDI-DI
- 00884999047730 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3956 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT).
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- cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 Systems — Roche Diagnostics Corp. · Class II
- RealTime — Abbott Molecular · Class II
- RealTime — Abbott Molecular · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI a155ae5c-eccd-4856-9cd8-c4bd883f3530 34 fields · synced May 29, 2026