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GenaCheck Rapid Self-Test Kit for FOB

FDA UDI

Class II (US FDA UDI)

by Genabio Diagnostics Inc.

Identity

Trade Name
GenaCheck Rapid Self-Test Kit for FOB FDA UDI
Generic Name
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
Model / Reference
RA9-E01701 FDA UDI

Identifiers

Primary DI / UDI-DI
00810143620023 FDA UDI
FDA Product Code
KHE FDA UDI
GMDN Term
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.6550 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Faecal occult blood IVD, kit, rapid ICT, clinical

GenaCheck Rapid Self-Test Kit for FOB by Genabio Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal occult blood IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genabio Diagnostics Inc.

Sources (1)

  • FDA UDI cd7f3838-3ccb-49c6-a09a-704b4d00920d 32 fields · synced May 30, 2026