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Tanner Scientific®

FDA UDI

Class II (US FDA UDI)

by Mercedes Medical Llc

Identity

Trade Name
Tanner Scientific® FDA UDI
Generic Name
Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 20/BX FDA UDI
Model / Reference
TNR IFOB FDA UDI
Description
Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 20/BX FDA UDI

Identifiers

Catalog Number
TNR IFOB FDA UDI
Primary DI / UDI-DI
00850011007150 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

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

Tanner Scientific® by Mercedes Medical Llc — 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
Mercedes Medical Llc

Sources (1)

  • FDA UDI 5d1f0c89-4d1f-4f18-8054-91f50ff2bf01 36 fields · synced Jun 1, 2026