1,423 results · 25ms · Sources: EU EUDAMED, US FDA

ABBOTT SPECTRUM AMYLASE REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABBOTT TDX/TDXFLX TT4

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABBOTT SPECTRUM GLUCOSE REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABBOTT VISION THEOPHYLLINE IIA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ABBOTT ARCHITECT GLYCATED HEMOGLOBIN

FDA 510(k)
FDA Class 2 ·Hematology

ABBOTT IMX FREE T4

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABBOTT ARCHITECT LH CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Abbott ARCHITECT Free T3

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABBOTT VISION HEMOGLOBIN (MODIFICATION)

FDA 510(k)
FDA Class 2 ·Hematology

ABBOTT QUICKSTART LDH,#5A31

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ABBOTT ARCHITECT HAVAB-M

FDA 510(k)
FDA Class 2 ·Microbiology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

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 ASSAY

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME CMV

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM AFP

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

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT ARCHITECHT AFP

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT IMX PSA

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