Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Pin, Fixation, Threaded

FDA classification

FDA Class 2 ·Pin, Fixation, Threaded

Pin, Fixation, Smooth

FDA classification

FDA Class 2 ·Pin, Fixation, Smooth

Pin, Fixation, Smooth, Metallic

FDA classification

FDA Class 2 ·Pin, Fixation, Smooth, Metallic

Pin, Fixation, Threaded, Metallic

FDA classification

FDA Class 2 ·Pin, Fixation, Threaded, Metallic

Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

FDA classification

FDA Class 2 ·Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

Gas Chromatography, Cocaine

FDA classification

FDA Class 2 ·Gas Chromatography, Cocaine

Pin, Fixation, Resorbable, Hard Tissue

FDA classification

FDA Class 2 ·Pin, Fixation, Resorbable, Hard Tissue

Galectin-3 In Vitro Diagnostic Assay

FDA classification

FDA Class 2 ·Galectin-3 In Vitro Diagnostic Assay

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

FDA classification

FDA Class 2 ·Tyrosine Phosphatase (Ia-2) Autoantibody Assay

Dengue Nucleic Acid Amplification Assay (Naat)

FDA classification

FDA Class 2 ·Dengue Nucleic Acid Amplification Assay (Naat)

Kit, Conception-Assist, Home Use

FDA classification

FDA Class 2 ·Kit, Conception-Assist, Home Use

Aquaporin-4 Autoantibody

FDA classification

FDA Class 2 ·Aquaporin-4 Autoantibody

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification

FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Sars-Cov-2 Serology Test

FDA classification

FDA Class 2 ·Sars-Cov-2 Serology Test

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

FDA classification

FDA Class 2 ·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anit-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601