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

Liquid Chromatography, Methadone

FDA classification

FDA Class 2 ·Liquid Chromatography, Methadone

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

Dna-Probe, B And T Lymphocyte

FDA classification

FDA Class 2 ·Dna-Probe, B And T Lymphocyte

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

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification

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

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

FDA Class 2 ·Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

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

Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

FDA Class 2 ·Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

FDA classification

FDA Class 2 ·Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

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

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

FDA classification

FDA Class 2 ·Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

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

Adhesive Backed Thermal Skin Patches

FDA classification

FDA Class 1 ·Adhesive Backed Thermal Skin Patches

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

FDA classification

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA classification

FDA Class 2 ·Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Physiological Signal Based Seizure Monitoring System

FDA classification

FDA Class 2 ·Physiological Signal Based Seizure Monitoring System

Mercury Vapor Lamp, Not Self-Extinguishing, R-Type

FDA classification

FDA Not Classified ·Mercury Vapor Lamp, Not Self-Extinguishing, R-Type