Identity
- Trade Name
- Panther Fusion® FDA UDI
- Generic Name
- Nucleic acid technique (NAT) kit IVD FDA UDI
- Device Name
- Panther Fusion® Open Access® Diluent Additive. FDA UDI
- Model / Reference
- LBLD, DILUENT ADDITIVE, OPEN ACCESS FDA UDI
- Description
- Panther Fusion® Open Access® Diluent Additive. FDA UDI
Identifiers
- Catalog Number
- PRD-04945 FDA UDI
- Primary DI / UDI-DI
- 15420045511071 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Nucleic acid technique (NAT) kit 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nucleic acid technique (NAT) kit IVD
Panther Fusion® by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Aptima® — Hologic, Inc. · Class I
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 b5647759-6c6e-4628-997f-093d9fac8a93 36 fields · synced May 29, 2026