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Healgen

FDA UDI

Class II (US FDA UDI)

by Healgen Scientific Limited Liability Company

Identity

Trade Name
Healgen FDA UDI
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing FDA UDI
Device Name
Healgen COVID-19 FLU A/B Combo De Novo Test FDA UDI
Model / Reference
GCFC-525SKa-H4 FDA UDI
Description
Healgen COVID-19 FLU A/B Combo De Novo Test FDA UDI

Identifiers

Primary DI / UDI-DI
00810173651257 FDA UDI
FDA Product Code
SCA FDA UDI
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3987 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

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Category: Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

Healgen by Healgen Scientific Limited Liability Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Healgen Scientific Limited Liability Company

Sources (1)

  • FDA UDI d2a83319-81e1-404f-a1f0-81eb1fd1c903 33 fields · synced May 30, 2026