57 results
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49ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV
VYSIS D7S486/CEP 7 FISH PROBE KIT
FDA 510(k)
FDA Class 2
·Hematology
Alinity m CMV
FDA 510(k)
FDA Class 2
·Microbiology
Alinity m BKV
FDA 510(k)
FDA Class 2
·Microbiology
Alinity m STI Assay
FDA 510(k)
FDA Class 2
·Microbiology
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
FDA 510(k)
FDA Class 2
·Microbiology
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
FDA 510(k)
FDA Class 2
·Immunology
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
FDA 510(k)
FDA Class 2
·Hematology
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
FDA 510(k)
FDA Class 2
·Immunology
Alinity m Resp-4-Plex
FDA 510(k)
FDA Class 2
·Microbiology
Alinity m HSV 1 & 2 / VZV
FDA 510(k)
FDA Class 2
·Microbiology
Alinity m STI Assay
FDA 510(k)
FDA Class 2
·Microbiology
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
FDA 510(k)
FDA Class 2
·Microbiology
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV Assay
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Alinity m HCV
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Alinity m HCV
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REALTIME HCV
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV Assay