← Back to catalogue

ImmunoCard Toxins A & B

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
ImmunoCard Toxins A & B FDA UDI
Generic Name
Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
ImmunoCard Toxins A & B is a rapid, qualitative, horizontal-flow enzyme immunoassay (EIA) for detecting Clostridium difficile Toxins A and B in human stool. This assay is used as an aid in the diagnosis of C. difficile-associated disease. In the US, ImmunoCard Toxins A & B is not intended for point-of-care use. The device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use. FDA UDI
Model / Reference
712050 FDA UDI
Description
ImmunoCard Toxins A & B is a rapid, qualitative, horizontal-flow enzyme immunoassay (EIA) for detecting Clostridium difficile Toxins A and B in human stool. This assay is used as an aid in the diagnosis of C. difficile-associated disease. In the US, ImmunoCard Toxins A & B is not intended for point-of-care use. The device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use. FDA UDI

Identifiers

Catalog Number
712050 FDA UDI
Primary DI / UDI-DI
00840733101786 FDA UDI
510(k) Number
K041003 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

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

ImmunoCard Toxins A & B by Meridian Bioscience, Inc. — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI a9b7567b-7574-4272-a0b3-36e10502a2e7 37 fields · synced May 30, 2026