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Rapid Response

FDA UDI

Class II (US FDA UDI)

by BTNX Inc

Identity

Trade Name
Rapid Response FDA UDI
Generic Name
Faecal occult blood IVD, kit, rapid ICT, self-testing FDA UDI
Device Name
Rapid Response Fecal Immunochemical Test - For the qualitative detection of human hemoglobin in feces. 2 tests/kit. FDA UDI
Model / Reference
FOB-9C2 FDA UDI
Description
Rapid Response Fecal Immunochemical Test - For the qualitative detection of human hemoglobin in feces. 2 tests/kit. FDA UDI

Identifiers

Primary DI / UDI-DI
10722066007102 FDA UDI
FDA Product Code
KHE FDA UDI
GMDN Term
Faecal occult blood IVD, kit, rapid ICT, self-testing 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

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: Faecal occult blood IVD, kit, rapid ICT, clinicalFaecal occult blood IVD, kit, rapid ICT, self-testing

Rapid Response by BTNX 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
BTNX Inc

Sources (1)

  • FDA UDI 196ca436-c5be-4494-a276-ad06dbdc6fad 33 fields · synced May 31, 2026