568 results · 40ms · Sources: EU EUDAMED, US FDA

Test, Urea (Breath Or Blood)

FDA classification
FDA Class 1 ·Test, Urea (Breath Or Blood)

Antisera, Latex Agglutination, Cryptococcus Neoformans

FDA classification
FDA Class 2 ·Antisera, Latex Agglutination, Cryptococcus Neoformans

Phages, Staphylococcal Typing, All Types

FDA classification
FDA Class 1 ·Phages, Staphylococcal Typing, All Types

Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

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

Stains, Microbiologic

FDA classification
FDA Class 1 ·Stains, Microbiologic

Over-The-Counter Covid-19 Antigen Test

FDA classification
FDA Class 2 ·Over-The-Counter Covid-19 Antigen Test

Reagent, Coronavirus Serological

FDA classification
FDA Not Classified ·Reagent, Coronavirus Serological

Susceptibility Test Plate, Antifungal

FDA classification
FDA Class 2 ·Susceptibility Test Plate, Antifungal

Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

FDA classification
FDA Unclassified ·Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA classification
FDA Class 2 ·System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

FDA classification
FDA Not Classified ·Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

FDA classification
FDA Class 2 ·Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

Hepatitis A Test (Antibody And Igm Antibody)

FDA classification
FDA Class 2 ·Hepatitis A Test (Antibody And Igm Antibody)

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

FDA classification
FDA Not Classified ·Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Antisera, Fluorescent, Pseudomonas Pseudomallei

FDA classification
FDA Class 2 ·Antisera, Fluorescent, Pseudomonas Pseudomallei

Reagents, 2019-Novel Coronavirus Nucleic Acid

FDA classification
FDA Not Classified ·Reagents, 2019-Novel Coronavirus Nucleic Acid

Antiserum, Fluorescent, Francisella Tularensis

FDA classification
FDA Class 2 ·Antiserum, Fluorescent, Francisella Tularensis

Antigen, Ha (Including Ha Control), Rubeola

FDA classification
FDA Class 1 ·Antigen, Ha (Including Ha Control), Rubeola

Susceptibility Test Discs, Antimicrobial

FDA classification
FDA Class 2 ·Susceptibility Test Discs, Antimicrobial

Respiratory Panel

FDA classification
FDA Class 2 ·Respiratory Panel