Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

FDA classification

FDA Class 2 ·Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

Mid-Stream Collection Kit

FDA classification

FDA Class 1 ·Mid-Stream Collection Kit

Radioimmunoassay, Androsterone

FDA classification

FDA Class 1 ·Radioimmunoassay, Androsterone

Gas Chromatography, Ethosuximide

FDA classification

FDA Class 2 ·Gas Chromatography, Ethosuximide

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA classification

FDA Class 3 ·Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

FDA classification

FDA Class 2 ·Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Medical Glove, Specialty

FDA classification

FDA Class 1 ·Medical Glove, Specialty

Refractive Corneal Implant

FDA classification

Refractive Corneal Implant

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

FDA classification

FDA Class 2 ·Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Hospital Cardiac Telemetry

FDA classification

FDA Class 2 ·Hospital Cardiac Telemetry

Latex Patient Examination Glove

FDA classification

FDA Class 1 ·Latex Patient Examination Glove

Vinyl Patient Examination Glove

FDA classification

FDA Class 1 ·Vinyl Patient Examination Glove

Personal Lubricant Ring

FDA classification

FDA Class 2 ·Personal Lubricant Ring

Lubricant, Personal

FDA classification

FDA Class 2 ·Lubricant, Personal

Surgeon'S Gloves

FDA classification

FDA Class 1 ·Surgeon'S Gloves

Real Time Nucleic Acid Amplification System

FDA classification

FDA Class 2 ·Real Time Nucleic Acid Amplification System

Polymer Patient Examination Glove

FDA classification

FDA Class 1 ·Polymer Patient Examination Glove

Tissue Adhesive For The Topical Approximation Of Skin

FDA classification

FDA Class 2 ·Tissue Adhesive For The Topical Approximation Of Skin