Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)— 510(k) DEN230092

Unknown

Diasorin Molecular, LLC

FDA 510(k) clearance DEN230092 for Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390), Unknown on 2024-07-15. Applicant: Diasorin Molecular, LLC.

Clearance details

Applicant
Diasorin Molecular, LLC
Product code
Code SBT
Advisory panel
Microbiology
Date received
Decision date
Decision
Unknown
Clearance type
Direct
Location
Cypress, CA, US
View on FDA.gov ↗

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