461 results · 23ms · Sources: EU EUDAMED, US FDA

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Eating Disorder Conditioning Tool

FDA classification
FDA Class 2 ·Eating Disorder Conditioning Tool

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Pump, Portable, Aspiration (Manual Or Powered)

FDA classification
FDA Class 2 ·Pump, Portable, Aspiration (Manual Or Powered)

Tester, Pacemaker Electrode Function

FDA classification
FDA Class 2 ·Tester, Pacemaker Electrode Function

Unit, Beta, Radiation, Ophthalmic

FDA classification
FDA Class 2 ·Unit, Beta, Radiation, Ophthalmic

Acid Phosphatase, Beta Glycerophosphate

FDA classification
FDA Class 2 ·Acid Phosphatase, Beta Glycerophosphate

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

FDA classification
FDA Class 2 ·Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification
FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE

Titrimetric With Edta And Indicator, Calcium

FDA classification
FDA Class 2 ·Titrimetric With Edta And Indicator, Calcium

Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes

FDA classification
FDA Class 2 ·Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes

System, Test, Beta-2-Microglobulin Immunological

FDA classification
FDA Class 2 ·System, Test, Beta-2-Microglobulin Immunological

P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin

FDA classification
FDA Class 2 ·P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin

Adjunctive Hemodynamic Indicator With Decision Point

FDA classification
FDA Class 2 ·Adjunctive Hemodynamic Indicator With Decision Point

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY

Ultrasonic Body Composition Analyzer

FDA classification
FDA Class 2 ·Ultrasonic Body Composition Analyzer

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

FDA classification
FDA Class 2 ·Adjunctive Hemodynamic Indicator With Decision Point For Military Use