Identity
- Trade Name
- Panther Fusion® FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, control FDA UDI
- Device Name
- Hologic CMV Plasmid Control. FDA UDI
- Model / Reference
- LBLD, CMV PLASMID (UNASSAYED CONTROL) FDA UDI
- Description
- Hologic CMV Plasmid Control. FDA UDI
Identifiers
- Catalog Number
- PRD-04987 FDA UDI
- Primary DI / UDI-DI
- 15420045512115 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) 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: Cytomegalovirus (CMV) 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 Cytomegalovirus (CMV) nucleic acid IVD, control.
- RealTime — Abbott Molecular · Class II
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- Exact Diagnostics — Exact Diagnostics · Class I
- Simplexa Congenital CMV Positive Control Pack — DiaSorin Molecular LLC · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
- Alinity m — Abbott Molecular · Class II
- Alethia™ CMV External Control Kit — MERIDIAN BIOSCIENCE, INC. · 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 d40e2ba0-d1bb-44cb-b07d-9b10fd826d0c 36 fields · synced May 30, 2026