Identity
- Trade Name
- Panther Fusion® FDA UDI
- Generic Name
- BK virus (BKV) nucleic acid IVD, control FDA UDI
- Device Name
- Hologic BKV Plasmid Control. FDA UDI
- Model / Reference
- LBLD, BKV PLASMID (UNASSAYED CONTROL) FDA UDI
- Description
- Hologic BKV Plasmid Control. FDA UDI
Identifiers
- Catalog Number
- PRD-04993 FDA UDI
- Primary DI / UDI-DI
- 15420045512139 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- BK virus (BKV) nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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: BK virus (BKV) nucleic acid IVD, control
Panther Fusion® by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as BK virus (BKV) nucleic acid IVD, control.
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- Alinity m — Abbott Molecular · Class II
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 ba1688e3-5298-49a0-8f86-0ff224aacf85 36 fields · synced Jun 8, 2026