Identity
- Trade Name
- Panther Fusion® FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
- Device Name
- Panther Fusion® Flu A/B/RSV Controls Kit. FDA UDI
- Model / Reference
- FLU A B RSV CTRLS, PANTHER FUSION, IVD FDA UDI
- Description
- Panther Fusion® Flu A/B/RSV Controls Kit. FDA UDI
Identifiers
- Catalog Number
- PRD-04336 FDA UDI
- Primary DI / UDI-DI
- 15420045509313 FDA UDI
- 510(k) Number
- K171963 FDA UDI
- FDA Product Code
- OCC FDA UDIOOI FDA UDI
- GMDN Term
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3980 FDA UDI862.2570 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, control
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, control.
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- Exact Diagnostics — Exact Diagnostics · Class I
- ACCURUN® — LGC Clinical Diagnostics, Inc.
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- Simplexa™ Flu A/B & RSV Positive Control Pack — DiaSorin Molecular LLC · Class II
- NATtrol™ — ZeptoMetrix LLC · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class I
- NATtrol™ — ZeptoMetrix LLC · Class I
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 a72e93ce-f5da-4cd0-b85c-29e4c7041bb7 37 fields · synced May 30, 2026