3,793 results
·
70ms
·
Sources: EU EUDAMED, US FDA
PCR INTERNATIONAL INC.
FDA registration
PCR INTERNATIONAL INC.·1 product·🇺🇸 United States
INTELISWAB COVID-19 RAPID TEST
FDA Adverse Event
Malfunction
·ORASURE TECHNOLOGIES, INC.·Product code QKP·February 27, 2023
INTELISWAB COVID-19 RAPID TEST
FDA Adverse Event
Malfunction
·ORASURE TECHNOLOGIES, INC.·Product code QKP·September 20, 2022
INTELISWAB COVID-19 RAPID TEST
FDA Adverse Event
Malfunction
·ORASURE TECHNOLOGIES, INC.·Product code QKP·September 26, 2022
INTELISWAB COVID-19 RAPID TEST
FDA Adverse Event
Malfunction
·ORASURE TECHNOLOGIES, INC.·Product code QKP·September 16, 2022
ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 22, 2023
BINAXNOW COVID-19 SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·February 26, 2022
TAQMAN HBV ANALYTE SPECIFIC REAGENT SET
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC.·Product code LOM·February 11, 2005
ID NOW COVID-19 ASSAY
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 1, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 28, 2022
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.
FDA Enforcement
Class III
·Terminated·Nanosphere, Inc.·August 20, 2014
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 19, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 25, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 28, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 1, 2022
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·February 26, 2022
ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 8, 2023
ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 7, 2023
ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 17, 2025
ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 15, 2023