191 results · 23ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ROCHE MOLECULAR SYSTEMS, INC.

FDA registration
ROCHE MOLECULAR SYSTEMS, INC.·48 products·🇺🇸 United States

FUSION FAST

FDA 510(k)
FDA Class 2 ·Dental

VERTEX Reconstruction System

FDA 510(k)
FDA Class 2 ·Orthopedic

COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD

FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013

COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD

FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013

COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD

FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013

COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD

FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013

COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 CE-IVD

FDA Adverse Event
ROCHE MOLECULAR SYSTEMS·Product code MZF·July 2, 2013

2243471-2019-00014

FDA Adverse Event
Malfunction ·March 26, 2019

2243471-2019-00013

FDA Adverse Event
Malfunction ·March 21, 2019

COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 8, 2021

COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 16, 2021

COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 15, 2021

COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·March 27, 2021

COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·July 14, 2021

COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·March 27, 2021

COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·March 27, 2021

COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·March 27, 2021

COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·June 21, 2021