Identity
- Trade Name
- Panther Fusion® FDA UDI
- Generic Name
- DNA amplification enzyme reagent IVD FDA UDI
- Device Name
- Panther Fusion® Open Access® RNA/DNA Enzyme Cartridge, 96 tests. FDA UDI
- Model / Reference
- KIT, OPEN ACCESS CARTRIDGES, 96-TEST, RNA/DNA ENZ FDA UDI
- Description
- Panther Fusion® Open Access® RNA/DNA Enzyme Cartridge, 96 tests. FDA UDI
Identifiers
- Catalog Number
- PRD-04303 FDA UDI
- Primary DI / UDI-DI
- 15420045515451 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- DNA amplification enzyme reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: DNA amplification enzyme reagent IVD
Panther Fusion® by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI d7b6cac0-77b6-4441-be49-28cb50342027 36 fields · synced May 30, 2026