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
Home/ Devices/ Simplexa C. auris Direct,…

Description

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) by Diasorin Molecular, LLC, an 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

Need More Information?

Contact the manufacturer or request a quote for this device.

Request Quote
Scroll to Top