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ADS Medical

FDA UDI

Class II (US FDA UDI)

by W.h.p.m. Inc.

Identity

Trade Name
ADS Medical FDA UDI
Generic Name
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
Device Name
ADS Medical iFOB Test Kit, 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer FDA UDI
Model / Reference
T1-CK30T-ADSM FDA UDI
Description
ADS Medical iFOB Test Kit, 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer FDA UDI

Identifiers

Primary DI / UDI-DI
00811925030023 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

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

ADS Medical by W.h.p.m. 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
W.h.p.m. Inc.

Sources (1)

  • FDA UDI 620d2c56-658e-424d-b222-73fe1b630b6d 33 fields · synced May 30, 2026