Saline, Vascular Access Flush

FDA classification

FDA Class 2 ·Saline, Vascular Access Flush

Radioimmunoassay, Cyclic Gmp

FDA classification

FDA Class 2 ·Radioimmunoassay, Cyclic Gmp

Controller, Temperature, Radiographic

FDA classification

FDA Class 2 ·Controller, Temperature, Radiographic

Injector, Vertebroplasty (Does Not Contain Cement)

FDA classification

FDA Class 1 ·Injector, Vertebroplasty (Does Not Contain Cement)

Hemodialysis Tray (Not A Start/Stop Kit)

FDA classification

FDA Class 2 ·Hemodialysis Tray (Not A Start/Stop Kit)

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification

FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

Internal Polymerase Chain Reaction Control, Not Assay Specific

FDA classification

FDA Class 1 ·Internal Polymerase Chain Reaction Control, Not Assay Specific

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

FDA classification

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

Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

FDA classification

FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

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

Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

FDA classification

FDA Not Classified ·Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

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

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA classification

FDA Class 2 ·Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

FDA classification

FDA Class 2 ·Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)

FDA classification

FDA Not Classified ·High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)

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.

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

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

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