276 results · 28ms · Sources: EU EUDAMED, US FDA

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 ·COBAS AMPLIPREP/COBAS TAQ/MAN CYTOMEGALOVIRUS TEST

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Aptima CMV Quant Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval
FDA Class 2 ·Cobas CMV

IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED

FDA 510(k)
FDA Class 2 ·Microbiology

FLUORESCENT TREPONEMEL ANTIBODY-ABSORB

FDA 510(k)
FDA Class 2 ·Microbiology

FTA-ABS TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·AL-47 SOFT CONTACT LENS

FTA-ABS BIOPAK

FDA 510(k)
FDA Class 2 ·Microbiology

FTA-ABS TEST

FDA 510(k)
FDA Class 2 ·Microbiology

LAB-TEK FTA-ABS KIT

FDA 510(k)
FDA Class 2 ·Microbiology

POLYCHACO FIA-ABS TEST FOR SYPHILIS

FDA 510(k)
FDA Class 2 ·Microbiology

QUICKVUE INFLUENZA A+B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)
FDA Class 2 ·Microbiology

OSOM INFLUENZA A&B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

FDA 510(k)
FDA Class 2 ·Microbiology

BD DIRECTIGEN FLU A+B

FDA 510(k)
FDA Class 2 ·Microbiology

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

FDA 510(k)
FDA Class 2 ·Microbiology