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ichroma™ iFOB

FDA UDI

Class II (US FDA UDI)

by Boditech Med, Inc.

Identity

Trade Name
ichroma™ iFOB FDA UDI
Generic Name
Faecal occult blood IVD, reagent FDA UDI
Model / Reference
CFPC-15 FDA UDI

Identifiers

Catalog Number
CFPC-15 FDA UDI
Primary DI / UDI-DI
08806679002718 FDA UDI
FDA Product Code
OOX FDA UDI
JJX FDA UDI
GMDN Term
Faecal occult blood IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.6550 FDA UDI
862.1660 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

Yes

FDA UDI

Category: Faecal occult blood IVD, reagent

ichroma™ iFOB by Boditech Med, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal occult blood IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boditech Med, Inc.

Sources (1)

  • FDA UDI c9dd660a-e75d-471c-9979-b43b1e4bdb75 34 fields · synced May 30, 2026