Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Aptima® HCV Quant Dx assay is a real-time transcription-mediated amplification (TMA®) test used for both detection and quantitation of hepatitis C virus (HCV) RNA. FDA UDI
- Model / Reference
- KIT, MAIN ASSAY, HCV QUANT, 100T, US IVD FDA UDI
- Description
- The Aptima® HCV Quant Dx assay is a real-time transcription-mediated amplification (TMA®) test used for both detection and quantitation of hepatitis C virus (HCV) RNA. FDA UDI
Identifiers
- Catalog Number
- ASY-08775 FDA UDI
- Primary DI / UDI-DI
- 15420045506787 FDA UDI
- PMA Number
- P160023 FDA UDI
- FDA Product Code
- MZP FDA UDI
- GMDN Term
- Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3170 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: Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 System — Roche Diagnostics Corp. · Class II
- VERSANT HCV 2.0 LiPA — Siemens Healthcare Diagnostics · Class II
- VERSANT HCV 2.0 LiPA — Siemens Healthcare Diagnostics · Class II
- COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0 — Roche Molecular Systems, Inc. · Class II
- VERSANT HCV 2.0 LiPA — Siemens Healthcare Diagnostics · Class II
- GeneXpert® — CEPHEID · Class II
- VERSANT HCV 2.0 LiPA — Siemens Healthcare Diagnostics · Class II
- cobas® HCV — Roche Molecular Systems, Inc. · Class II
Cleared under the same submission
P160023 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 b1f8f996-4d10-4a45-87f4-f32dcae52ccf 37 fields · synced Jun 8, 2026