237 results · 44ms · Sources: EU EUDAMED, US FDA

GenePOC Strep A

FDA 510(k)
FDA Class 2 ·Microbiology

TDX PRIMIDONE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACE PRIMIDONE REAGENT, AED CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Respiratory virus panel nucleic acid assay system

FDA registration
ENERCON TECHNOLOGIES·4 products·🇺🇸 United States

StarMed Plus/StarMed Select Nitrile Exam Glove

FDA UDI
SEMPERMED USA, INC.·00841277107159·StarMed Plus/StarMed Select Nitrile Exam Glove,...

SemperForce Nitrile Exam Glove

FDA UDI
SEMPERMED USA, INC.·00841277101058·SemperForce Nitrile Exam Glove, size M

SPOTFIRE R/ST Panel Mini

FDA registration
BioFire Diagnostics, LLC·5 products·🇺🇸 United States

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV

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 ·COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Alinity m CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan CMV Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV Test for use on the cobas 6800/8800 System

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

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