Identity
- Trade Name
- Exact Diagnostics FDA UDI
- Generic Name
- HIV1 nucleic acid IVD, control FDA UDI
- Device Name
- HIV-1 Low Run Control FDA UDI
- Model / Reference
- HIVL101 FDA UDI
- Description
- HIV-1 Low Run Control FDA UDI
Identifiers
- Catalog Number
- HIVL101 FDA UDI
- Primary DI / UDI-DI
- 00812242030017 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- HIV1 nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: HIV1 nucleic acid IVD, control
Exact Diagnostics by Exact Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as HIV1 nucleic acid IVD, control.
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- Alinity m — Abbott Molecular · Class II
- RealTime — Abbott Molecular · Class II
- Procleix HIV-1/HCV/HBV Quality Control — Grifols Diagnostic Solutions Inc. · Class II
- APTIMA® — Hologic, Inc. · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Exact Diagnostics — Exact Diagnostics · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Exact Diagnostics
Sources (1)
- FDA UDI be4b2e37-0e5b-4d0c-9475-95d0def4f092 36 fields · synced Jun 9, 2026