450 results · 29ms · Sources: EU EUDAMED, US FDA

FLIPSCREEN (TM) TOTAL E IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Immunology

VALIDATE Heparin Calibration Verification/Linearity Test Kit

FDA 510(k)
FDA Class 2 ·Hematology

EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120

FDA 510(k)
FDA Class 2 ·General Hospital

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)
FDA Class 2 ·Microbiology

VENTREX ALLERGEN DISC

FDA 510(k)
FDA Class 2 ·Immunology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)
FDA Class 2 ·Microbiology

OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES

FDA 510(k)
FDA Class 2 ·Hematology

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)
FDA Class 2 ·Microbiology

VISIONLINK INTERFILE CONVERSION SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

SPECIFIC IGE EIA-TURBO ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

BINAX LEGIONELLA URINARY ANTIGEN EIA

FDA 510(k)
FDA Class 2 ·Microbiology

VENTRESCREEN, HCG URINE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MICRO TARGETING DRIVE SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

MICROTABLE SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

MICROTARGETING XL STAR DRIVE SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

FETALTROL

FDA 510(k)
FDA Class 2 ·Hematology

VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

FDA 510(k)
FDA Class 2 ·Microbiology

Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

FDA 510(k)
FDA Class 2 ·Microbiology

BinaxNOW G6PD Test

FDA 510(k)
FDA Class 2 ·Hematology