8,389 results · 43ms · Sources: EU EUDAMED, US FDA

Assay, Enterovirus Nucleic Acid

FDA classification
FDA Class 2 ·Assay, Enterovirus Nucleic Acid

Antigens (Febrile), Agglutination, Brucella Spp.

FDA classification
FDA Class 2 ·Antigens (Febrile), Agglutination, Brucella Spp.

C. Difficile Toxin Gene Amplification Assay

FDA classification
FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

Direct Blood Bacterial Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Direct Blood Bacterial Nucleic Acid Detection System

Variola Virus Nucleic Acid-Based Detection Assay

FDA classification
FDA Class 2 ·Variola Virus Nucleic Acid-Based Detection Assay

Assay, Endotoxin Activity, Chemiluminescent

FDA classification
FDA Class 2 ·Assay, Endotoxin Activity, Chemiluminescent

Antigen, Ha (Including Ha Control), Rubella

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

Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

FDA classification
FDA Class 2 ·Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

Procalcitonin Assay

FDA classification
FDA Class 2 ·Procalcitonin Assay

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

FDA classification
FDA Class 2 ·System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Antisera, Fluorescent, Cryptococcus Neoformans

FDA classification
FDA Class 2 ·Antisera, Fluorescent, Cryptococcus Neoformans

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA classification
FDA Class 2 ·System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

FDA classification
FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

FDA classification
FDA Class 2 ·Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

FDA classification
FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

Candida Spp., Direct Antigen, Id

FDA classification
FDA Class 2 ·Candida Spp., Direct Antigen, Id

Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

FDA classification
FDA Class 2 ·Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

FDA classification
FDA Class 2 ·Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Chlamydophila Pneumoniae Dna Assay System

FDA classification
FDA Class 2 ·Chlamydophila Pneumoniae Dna Assay System

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA classification
FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna