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COMPLIANCE GOLD iFOB SIMPLE

FDA UDI

Class II (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
COMPLIANCE GOLD iFOB SIMPLE FDA UDI
Generic Name
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples. FDA UDI
Model / Reference
74030 FDA UDI
Description
Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples. FDA UDI

Identifiers

Primary DI / UDI-DI
00695684740306 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

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

COMPLIANCE GOLD iFOB SIMPLE by Germaine Laboratories, 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
Germaine Laboratories, Inc.

Sources (1)

  • FDA UDI e7286ae6-ee15-41de-bd6a-23e844a24221 33 fields · synced Jun 1, 2026