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ProSpecT C. difficile Toxin A/B Microplate

FDA UDI

Class I (US FDA UDI)

by Oxoid Limited

Identity

Trade Name
ProSpecT C. difficile Toxin A/B Microplate FDA UDI
Generic Name
Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
R244596 FDA UDI

Identifiers

Primary DI / UDI-DI
05032384519903 FDA UDI
FDA Product Code
LLH FDA UDI
GMDN Term
Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

ProSpecT C. difficile Toxin A/B Microplate by Oxoid Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oxoid Limited

Sources (1)

  • FDA UDI 0fc963b4-5202-4fd3-af19-0c92dfdd6d9d 32 fields · synced May 30, 2026