← Back to catalogue

Panther Fusion®

FDA UDI

Class I (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Panther Fusion® FDA UDI
Generic Name
Beta-haemolytic Group B Streptococcus nucleic acid IVD, control FDA UDI
Device Name
Panther Fusion® GBS Controls Kit. FDA UDI
Model / Reference
KIT, GBS CONTROLS, FUSION, IVD FDA UDI
Description
Panther Fusion® GBS Controls Kit. FDA UDI

Identifiers

Catalog Number
PRD-04485 FDA UDI
Primary DI / UDI-DI
15420045510906 FDA UDI
FDA Product Code
NJR FDA UDI
OOI FDA UDI
GMDN Term
Beta-haemolytic Group B Streptococcus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3740 FDA UDI
862.2570 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: Beta-haemolytic Group B Streptococcus 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 Beta-haemolytic Group B Streptococcus nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 52fd4c28-8ee1-48f6-a5b7-39aa7c063a3f 36 fields · synced Jun 8, 2026