591 results · 39ms · Sources: EU EUDAMED, US FDA

Antigen, Positive Control, Cryptococcus Neoformans

FDA classification
FDA Class 2 ·Antigen, Positive Control, Cryptococcus Neoformans

Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA classification
FDA Class 2 ·Herpes Simplex Virus Nucleic Acid Amplification Assay

Antigen, Treponema Pallidum For Fta-Abs Test

FDA classification
FDA Class 2 ·Antigen, Treponema Pallidum For Fta-Abs Test

Covid-19 Test Home Collection Kit Devices

FDA classification
FDA Not Classified ·Covid-19 Test Home Collection Kit Devices

Antiserum, Neutralization, Rubeola

FDA classification
FDA Class 1 ·Antiserum, Neutralization, Rubeola

Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus

FDA classification
FDA Class 2 ·Antigens, Indirect Hemagglutination (Iha) Herpes Simplex Virus

Quality Control Slides

FDA classification
FDA Class 1 ·Quality Control Slides

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

FDA classification
FDA Class 2 ·Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

Covid-19 Multi-Analyte Antigen Device

FDA classification
FDA Not Classified ·Covid-19 Multi-Analyte Antigen Device

Plasmodium Spp. Detection Reagents

FDA classification
FDA Class 2 ·Plasmodium Spp. Detection Reagents

Culture Media, Antimycobacteria, Susceptibility Test

FDA classification
FDA Class 2 ·Culture Media, Antimycobacteria, Susceptibility Test

Dengue Nucleic Acid Amplification Assay (Naat)

FDA classification
FDA Class 2 ·Dengue Nucleic Acid Amplification Assay (Naat)

Staphylococcus Aureus Somatic Antigens

FDA classification
FDA Class 1 ·Staphylococcus Aureus Somatic Antigens

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

Deformability Cytometry For Sepsis Risk Assessment

FDA classification
FDA Class 2 ·Deformability Cytometry For Sepsis Risk Assessment

Culture Media, Antimicrobial Susceptibility Test

FDA classification
FDA Class 2 ·Culture Media, Antimicrobial Susceptibility Test

Reagents, Non-Variola Orthopoxvirus Nucleic Acid.

FDA classification
FDA Not Classified ·Reagents, Non-Variola Orthopoxvirus Nucleic Acid.

Antisera, All Mycoplasma Spp.

FDA classification
FDA Class 1 ·Antisera, All Mycoplasma Spp.

Antigen, Cf (Including Cf Control), Rubella

FDA classification
FDA Class 2 ·Antigen, Cf (Including Cf Control), Rubella

Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test

FDA classification
FDA Class 2 ·Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test