Radioimmunoassay, Follicle-Stimulating Hormone

FDA classification

FDA Class 1 ·Radioimmunoassay, Follicle-Stimulating Hormone

Radioimmunoassay, Androsterone

FDA classification

FDA Class 1 ·Radioimmunoassay, Androsterone

System, Test, Biotinidase

FDA classification

FDA Class 2 ·System, Test, Biotinidase

Radioimmunoassay (Two-Site Solid Phase), Ferritin

FDA classification

FDA Class 2 ·Radioimmunoassay (Two-Site Solid Phase), Ferritin

Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase

FDA classification

FDA Class 1 ·Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase

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

Electrode, Ion Specific, Sodium

FDA classification

FDA Class 2 ·Electrode, Ion Specific, Sodium

Phosphomolybdate (Colorimetric), Inorganic Phosphorus

FDA classification

FDA Class 1 ·Phosphomolybdate (Colorimetric), Inorganic Phosphorus

Photometric Method, Ammonia

FDA classification

FDA Class 1 ·Photometric Method, Ammonia

Tetrabromo-M-Cresolsulfonphthalein, Albumin

FDA classification

FDA Class 2 ·Tetrabromo-M-Cresolsulfonphthalein, Albumin

Acid, Uric, Uricase (Colorimetric)

FDA classification

FDA Class 1 ·Acid, Uric, Uricase (Colorimetric)

Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

FDA classification

FDA Not Classified ·Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride

FDA classification

FDA Class 2 ·Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

FDA classification

FDA Class 1 ·Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Immunoassay For Detection Of Amniotic Fluid Protein(S).

FDA classification

FDA Class 1 ·Immunoassay For Detection Of Amniotic Fluid Protein(S).

Blood And Urine Collection Kit (Excludes Hiv Testing)

FDA classification

FDA Class 1 ·Blood And Urine Collection Kit (Excludes Hiv Testing)

Enzymatic Method, Creatinine

FDA classification

FDA Class 2 ·Enzymatic Method, Creatinine

Column Chromatography & Color Development, Hydroxyproline

FDA classification

FDA Class 1 ·Column Chromatography & Color Development, Hydroxyproline

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

FDA classification

FDA Class 1 ·Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Dialyzer

FDA classification

FDA Class 1 ·Dialyzer