Apparatus, Melting Point, Paraffin

FDA classification

FDA Class 1 ·Apparatus, Melting Point, Paraffin

Implantable Radio Frequency Transponder System

FDA classification

FDA Class 2 ·Implantable Radio Frequency Transponder System

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

FDA classification

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

Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

Ldt, Approved By Nys Clep

FDA classification

FDA Not Classified ·Ldt, Approved By Nys Clep

Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

FDA classification

FDA Class 2 ·Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification

FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

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

Antigen, Id, Candida Albicans

FDA classification

FDA Class 2 ·Antigen, Id, Candida Albicans

Rf Identification

FDA classification

FDA Not Classified ·Rf Identification

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

FDA classification

FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Candida Spp., Direct Antigen, Id

FDA classification

FDA Class 2 ·Candida Spp., Direct Antigen, Id

Reprocessed Bronchoscope

FDA classification

FDA Class 2 ·Reprocessed Bronchoscope

Antigen, Cf And / Or Id, Coccidioides Immitis

FDA classification

FDA Class 2 ·Antigen, Cf And / Or Id, Coccidioides Immitis

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

FDA classification

FDA Class 2 ·Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

FDA classification

FDA Class 2 ·System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection