Identity
- Trade Name
- Panther Fusion® FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Panther Fusion® Specimen Lysis Tubes. FDA UDI
- Model / Reference
- SPECIMEN LYSIS TUBES, IVD FDA UDI
- Description
- Panther Fusion® Specimen Lysis Tubes. FDA UDI
Identifiers
- Catalog Number
- PRD-04339 FDA UDI
- Primary DI / UDI-DI
- 15420045509238 FDA UDI
- 510(k) Number
- K171963 FDA UDI
- FDA Product Code
- OCC FDA UDI
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3980 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: Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Panther Fusion® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Respiratory Pathogens Flex (RP Flex) Extraction Tray — Luminex Corporation · Class II
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES LIMITED · Class II
- Lyra — DIAGNOSTIC HYBRIDS, INC. · Class II
- BD Respiratory Viral Panel for BD MAX™ System — BECTON DICKINSON AND COMPANY · Class II
- Simplexa COVID-19 & Flu A/B Direct — DiaSorin Molecular LLC · Class II
- Alinity m — Abbott Molecular · N
- TaqPath™ COVID-19, Flu A, Flu B, RSV Select Assay — LIFE TECHNOLOGIES LIMITED · Class II
- Solana — DIAGNOSTIC HYBRIDS, INC. · Class II
Cleared under the same submission
K171963 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 fe01002a-09d7-4cd2-9fdd-62e7e97356d9 37 fields · synced Jun 8, 2026