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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, clinical FDA UDI
Device Name
Rapid Response FIT Mailers&Buffers&Cassettes - 36 Mailers + Buffers + Cassettes/Box FDA UDI
Model / Reference
FOB-0MBC FDA UDI
Description
Rapid Response FIT Mailers&Buffers&Cassettes - 36 Mailers + Buffers + Cassettes/Box FDA UDI

Identifiers

Primary DI / UDI-DI
00722066004999 FDA UDI
510(k) Number
K110309 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

No

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, clinical

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.

Cleared under the same submission

K110309 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BTNX Inc

Sources (1)

  • FDA UDI cc3cb2c1-a79f-4c2d-a484-a73227d45bc3 34 fields · synced May 30, 2026