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Clostridium dificile GDH, Toxin A and Toxin B Combo Rapid Test

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06974238910711
Basic UDI-DI Code
B-06974238910711
Reference
HCDT067G
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

The Clostridium difficile GDH, Toxin A and Toxin B combo Rapid Test is a test for the detection of glutamate dehydrogenase antigen and toxins A and B. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile, and confirms the presence of toxigenic C. difficile by detecting toxins A and B in stool specimens from people suspected of having C. difficile which is a difficult disease. The test will serve as an adjunct to the diagnosis of clostridium difficile. As with other C. difficile tests, the results should be considered in conjunction with the patient's medical history.

CND Nomenclature Codes

Code Description
W0105011802 C.DIFFICILE TOXIN A/B DETECTION

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