Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Aptima® HBV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system. FDA UDI
- Model / Reference
- KIT, MAIN ASSAY, HBV, VL, 100T, US IVD FDA UDI
- Description
- The Aptima® HBV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system. FDA UDI
Identifiers
- Catalog Number
- ASY-10269 FDA UDI
- Primary DI / UDI-DI
- 15420045506749 FDA UDI
- PMA Number
- P170025 FDA UDI
- FDA Product Code
- MKT FDA UDI
- GMDN Term
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3174 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 B 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 B virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Alinity m — Abbott Molecular · Class II
- RealTime — Abbott Molecular · Class II
- cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System — Roche Diagnostics Corp. · Class II
- COBAS® TaqMan® HBV Test, For Use With The High Pure System — Roche Molecular Systems, Inc. · Class II
- cobas® HBV — Roche Molecular Systems, Inc. · Class II
- RealTime — Abbott Molecular · Class II
Cleared under the same submission
P170025 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
- Hologic, Inc.
Sources (1)
- FDA UDI 1b24bbd1-2f96-4cda-bffa-4d688e0e036c 37 fields · synced Jun 8, 2026