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Panther®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Panther® FDA UDI
Generic Name
Isothermal nucleic acid amplification analyser IVD, laboratory FDA UDI
Device Name
Panther® Instrument System. FDA UDI
Model / Reference
PANTHER, INSTRUMENT SYSTEM FDA UDI
Description
Panther® Instrument System. FDA UDI

Identifiers

Catalog Number
902615 FDA UDI
Primary DI / UDI-DI
15420045504141 FDA UDI
FDA Product Code
NSU FDA UDI
OOI FDA UDI
GMDN Term
Isothermal nucleic acid amplification analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Isothermal nucleic acid amplification analyser IVD, laboratory

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

Similar devices

Also classified as Isothermal nucleic acid amplification analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 17239999-8d87-4ba9-923e-6481083ef84c 35 fields · synced Jun 1, 2026