Identity
- Trade Name
- APTIMA® FDA UDI
- Generic Name
- HIV1 nucleic acid IVD, control FDA UDI
- Device Name
- Aptima® HIV-1 Quant Dx Assay Controls Kit. FDA UDI
- Model / Reference
- KIT, CONTROLS, HIV QUANT, US IVD FDA UDI
- Description
- Aptima® HIV-1 Quant Dx Assay Controls Kit. FDA UDI
Identifiers
- Catalog Number
- PRD-03567 FDA UDI
- Primary DI / UDI-DI
- 15420045504233 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1 nucleic acid IVD, control 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: HIV1 nucleic acid IVD, control
Aptima® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1 nucleic acid IVD, control.
- MAS HIV p24 Positive Control — Microgenics Corporation · Class I
- Acrometrix BB NAT HIV-1 POS. CTRL — Microgenics Corporation · Class II
- Alinity m — Abbott Molecular · Class II
- RealTime — Abbott Molecular · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Procleix HIV-1/HCV/HBV Quality Control — Grifols Diagnostic Solutions Inc. · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
Cleared under the same submission
BP150318 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI d7d66883-562d-4910-91c6-465e534dacb5 37 fields · synced May 30, 2026