Class Class II

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) (DEN230092)

DEN230092 2024-07-15 Direct
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Description

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) by Diasorin Molecular, LLC — FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN230092
Clearance Date2024-07-15
Clearance TypeDirect
Product CodeSBT
Regulation Number866.3967

Categories

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