1,423 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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