58 results
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48ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIAGNOSTIC BIOSYSTEMS
FDA registration
DIAGNOSTIC BIOSYSTEMS·5 products·🇺🇸 United States
Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
FDA 510(k)
FDA Class 2
·Microbiology
PELORIS II RAPID TISSUE PROCESSOR
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS MELBOURNE PTY. LTD·Product code IEO·January 7, 2022
PELORIS RAPID TISSUE PROCESSOR
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS MELBOURNE PTY. LTD·Product code IEO·March 16, 2019
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code NSU·December 9, 2013
3500 XL DX GENETIC ANALYZER CS2
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD·Product code PCA·March 6, 2014
3500 XL DX GENETIC ANALYZER CS2
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code PCA·March 27, 2014
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control
FDA UDI
LIFE TECHNOLOGIES CORPORATION·10190302019446·Part 2 of 3 of TaqPath™ COVID-19 Diagnostic PCR...
VERITI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code NSU·January 15, 2014
VERITI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code OUL·April 21, 2014
LEICA ASP300 S
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS NUSSLOCH GMBH·Product code IEO·December 11, 2025
PELORIS II AUTOMATED TISSUE PROCESSOR
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS MELBOURNE PTY. LTD·Product code IEO·May 15, 2025
PELORIS RAPID TISSUE PROCESSOR
FDA Adverse Event
Malfunction
·LEICA BIOSYSTEMS MELBOURNE PTY. LTD.·Product code IEO·August 3, 2016
VERTI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code OUL·May 2, 2014
VERITI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code NSU·December 9, 2013
VERITI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD·Product code NSU·December 23, 2013
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit
FDA UDI
LIFE TECHNOLOGIES CORPORATION·10190302019422·Part 1 of 3 of TaqPath™ COVID-19 Diagnostic PCR...
VERITI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDING PTE. LTD·Product code NSU·March 6, 2014
VERITI DX THERMAL CYCLER
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES HOLDINGS PTE. LTD.·Product code NSU·March 25, 2014
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer
FDA UDI
LIFE TECHNOLOGIES CORPORATION·10190302019439·Part 3 of 3 of TaqPath™ COVID-19 Diagnostic PCR...