Identity
- Trade Name
- RealTime FDA UDI
- Generic Name
- HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Abbott RealTime HIV-1 Amplification Reagent Extended Use FDA UDI
- Model / Reference
- 6L18-50 FDA UDI
- Description
- Abbott RealTime HIV-1 Amplification Reagent Extended Use FDA UDI
Identifiers
- Catalog Number
- 6L18-50 FDA UDI
- Primary DI / UDI-DI
- 00884999037304 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
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
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)
RealTime 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).
- cobas® HIV-1 — Roche Molecular Systems, Inc. · Class II
- APTIMA® — Hologic, Inc. · Class II
- COBAS® AmpliPrep/ COBAS® TaqMan® HIV- 1 Test, version 2.0 — Roche Molecular Systems, Inc. · Class II
- COBAS® TaqMan® HIV-1 Test version 2.0, For Use With the High Pure System — Roche Molecular Systems, Inc. · Class II
- cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 Systems — Roche Diagnostics Corp. · Class II
- RealTime — Abbott Molecular · Class II
- Alinity m — Abbott Molecular · Class II
Cleared under the same submission
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 7d7550a0-4f48-447e-bb51-fab490957838 36 fields · synced May 30, 2026