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Gazelle PathoCatch

FDA UDI

Class N (US FDA UDI)

by Mylab Discovery Solutions Private Limited

Identity

Trade Name
Gazelle PathoCatch FDA UDI
Generic Name
SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid FDA UDI
Device Name
COVID-19 Antigen Fluorescence Immunoassay Kit FDA UDI
Model / Reference
MGPF25 FDA UDI
Description
COVID-19 Antigen Fluorescence Immunoassay Kit FDA UDI

Identifiers

Catalog Number
MGPF25 FDA UDI
Primary DI / UDI-DI
08908016644022 FDA UDI
FDA Product Code
QKP FDA UDI
GMDN Term
SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid FDA UDI

Classification

Device Class
N FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Category: SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

Gazelle PathoCatch by Mylab Discovery Solutions Private Limited — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mylab Discovery Solutions Private Limited

Sources (1)

  • FDA UDI 48453e87-2479-4d6e-8799-04aa977f5841 35 fields · synced May 30, 2026