27 results · 17ms · Sources: EU EUDAMED, US FDA

Membrane Osmometry, Plasma Oncometry

FDA classification
FDA Class 1 ·Membrane Osmometry, Plasma Oncometry

Kit, Identification, Neisseria Gonorrhoeae

FDA Pre-Market Approval
FDA Class 1 ·GONOSTICON DRI-DOT TEST

Kit, Identification, Neisseria Gonorrhoeae

FDA Pre-Market Approval
FDA Class 1 ·GONOCOCCAL PILI ANTIBODY TEST

Kit, Identification, Neisseria Gonorrhoeae

FDA Pre-Market Approval
FDA Class 1 ·GONOSTICON DRI-DOT

VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES

FDA 510(k)
FDA Class 1 ·Microbiology

REMEL XPECT FLU A&B

FDA 510(k)
FDA Class 1 ·Microbiology

ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A

FDA 510(k)
FDA Class 1 ·Microbiology

INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION

FDA 510(k)
FDA Class 1 ·Microbiology

SAS FLUALERT A & B, SAS INFLUENZA A TEST

FDA 510(k)
FDA Class 1 ·Microbiology

FMS HIGH FLOW ARTHRO-SHEATH

FDA 510(k)
FDA Class 1 ·Ophthalmic

QUICKVUE INFLUENZA A+B

FDA 510(k)
FDA Class 1 ·Microbiology

SOFIA INFLUENZA A+B FIA

FDA 510(k)
FDA Class 1 ·Microbiology

FMS ARTHRO-CUTTER

FDA 510(k)
FDA Class 1 ·Ophthalmic

ALERE BINAXNOW INFLUENZA A & B CARD

FDA 510(k)
FDA Class 1 ·Microbiology

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B

FDA 510(k)
FDA Class 1 ·Microbiology

IMAGEN INFLUENZA VIRUS A AND B TESTMI

FDA 510(k)
FDA Class 1 ·Microbiology

QUICK VUE INFLUENZA

FDA 510(k)
FDA Class 1 ·Microbiology

INFLUENZA A2 VIRUS

FDA 510(k)
FDA Class 1 ·Microbiology

BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY

FDA 510(k)
FDA Class 1 ·Microbiology

IN FLUENZA B VIRUS

FDA 510(k)
FDA Class 1 ·Microbiology