510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190016Unknown

cobas vivoDx MRSA

Roche Molecular Systems Inc, Pleasanton CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN190016 is the FDA 510(k) clearance record for cobas vivoDx MRSA, a class II device, cleared for Roche Molecular Systems, Inc. on under FDA product code QIV (Culture-Based Short-Term Incubation Antimicrobial Resistance Assay). FDA's definition for product code QIV reads: "A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated...". FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show no recalls naming DEN190016.

Clearance record

Decision date
Received
(261 days to decision)
Product code
QIV Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
Regulation
21 CFR 866.1655
Device class
Class II
Review panel
Microbiology
Applicant
Roche Molecular Systems, Inc. 4300 Hacienda Dr., Pleasanton CA
Third party review
No

Clearances, product code QIV

Trailing 12 months

FDA records hold no clearances under product code QIV in the trailing twelve months.

FDA records show no clearances under product code QIV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QIV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260