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Panther Fusion®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Panther Fusion® FDA UDI
Generic Name
Nucleic acid technique (NAT) kit IVD FDA UDI
Device Name
Panther Fusion® Extraction Reagents-S. FDA UDI
Model / Reference
KIT, EXTRACTION REAGENTS - S, FUSION, IVD FDA UDI
Description
Panther Fusion® Extraction Reagents-S. FDA UDI

Identifiers

Catalog Number
PRD-04331 FDA UDI
Primary DI / UDI-DI
15420045509214 FDA UDI
FDA Product Code
OOU FDA UDI
QOF FDA UDI
JJH FDA UDI
OEM FDA UDI
OCC FDA UDI
GMDN Term
Nucleic acid technique (NAT) kit IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3980 FDA UDI
866.3981 FDA UDI
862.2310 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: Nucleic acid technique (NAT) kit IVD

Panther Fusion® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid technique (NAT) kit IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 7085a4ab-a50e-4a77-93dd-1ec0ffb2b3b6 36 fields · synced May 30, 2026