568 results · 43ms · Sources: EU EUDAMED, US FDA

Antigen, Invasive Fungal Pathogens

FDA classification
FDA Class 2 ·Antigen, Invasive Fungal Pathogens

Kit, Identification, Enterobacteriaceae

FDA classification
FDA Class 1 ·Kit, Identification, Enterobacteriaceae

Test, Antigen, Nuclear, Epstein-Barr Virus

FDA classification
FDA Class 1 ·Test, Antigen, Nuclear, Epstein-Barr Virus

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification
FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Antisera, Agglutinating, B. Parapertussis

FDA classification
FDA Class 1 ·Antisera, Agglutinating, B. Parapertussis

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

FDA classification
FDA Class 1 ·Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

Gram Negative Identification Panel

FDA classification
FDA Class 1 ·Gram Negative Identification Panel

Exoenzymes, Multiple, Streptococcal

FDA classification
FDA Class 1 ·Exoenzymes, Multiple, Streptococcal

Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

FDA classification
FDA Class 1 ·Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

Candida Species, Antibody Detection

FDA classification
FDA Class 2 ·Candida Species, Antibody Detection

Antigens, Slide And Tube, Francisella Tularensis

FDA classification
FDA Class 2 ·Antigens, Slide And Tube, Francisella Tularensis

Media, Culture, Amino Acid Assay

FDA classification
FDA Class 1 ·Media, Culture, Amino Acid Assay

Anti-Jcv Antibody Detection Assay

FDA classification
FDA Class 2 ·Anti-Jcv Antibody Detection Assay

Sars-Cov-2 Serology Test

FDA classification
FDA Class 2 ·Sars-Cov-2 Serology Test

Antigens, Cf (Including Cf Control), Reovirus 1-3

FDA classification
FDA Class 1 ·Antigens, Cf (Including Cf Control), Reovirus 1-3

Dna-Probe, Reagent, Histoplasma Capsulatum

FDA classification
FDA Class 2 ·Dna-Probe, Reagent, Histoplasma Capsulatum

Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis

FDA classification
FDA Class 1 ·Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis

Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

FDA classification
FDA Class 2 ·Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

FDA classification
FDA Class 2 ·Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Dna Probe, Gardnerella Vaginalis

FDA classification
FDA Class 1 ·Dna Probe, Gardnerella Vaginalis