989 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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QUANTA LITE SS-A 52 ELISA
FDA 510(k)
FDA Class 2
·Immunology
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
ANEUVYSION
FDA 510(k)
FDA Class 2
·Immunology
Aptima CMV Quant Assay
FDA 510(k)
FDA Class 2
·Microbiology
illumigene Mycoplasma DNA Amplification Assay
FDA 510(k)
FDA Class 2
·Microbiology
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
FDA 510(k)
FDA Class 2
·Microbiology
HEMOSIL F11 & FV DNA CONTROL
FDA 510(k)
FDA Class 2
·Microbiology
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
FDA 510(k)
FDA Class 2
·Microbiology
Great Basin Bordetella Direct Test
FDA 510(k)
FDA Class 2
·Microbiology
ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
Ion PGM Dx System
FDA 510(k)
FDA Class 2
·Immunology
ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
ANEUVYSION MULITICOLOR DNA PROBE KIT
FDA 510(k)
FDA Class 2
·Immunology
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
FDA 510(k)
FDA Class 2
·Microbiology
illumigene Pertussis DNA Amplification Assay
FDA 510(k)
FDA Class 2
·Microbiology
GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
FDA 510(k)
FDA Class 2
·Microbiology
ILLUMINA MISEQDX PLATFORM
FDA 510(k)
FDA Class 2
·Immunology
ANAZYME ANA PEROXIDASE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology