Identity
- Trade Name
- Alinity m FDA UDI
- Generic Name
- Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Alinity m HSV 1 & 2 / VZV AMP Kit FDA UDI
- Model / Reference
- 09N61-095 FDA UDI
- Description
- Alinity m HSV 1 & 2 / VZV AMP Kit FDA UDI
Identifiers
- Catalog Number
- 09N61-095 FDA UDI
- Primary DI / UDI-DI
- 00884999050594 FDA UDI
- 510(k) Number
- K233349 FDA UDI
- FDA Product Code
- PGI FDA UDI
- GMDN Term
- Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3309 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
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: Multiple Human herpesvirus 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 Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Solana — DIAGNOSTIC HYBRIDS, INC. · Class II
- Lyra — Quidel Corp. · Class II
Cleared under the same submission
K233349 also covers:
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 1b141f61-3f91-4e6c-8870-9cdeb4b3d7ec 37 fields · synced May 29, 2026