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C. Difficile Nucleic Acid Amplification Test Assay

FDA product code OMN · 4 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.2660
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2010-07-09 – 2012-04-04

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

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