57 results · 49ms · Sources: EU EUDAMED, US FDA

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