603 results · 42ms · Sources: EU EUDAMED, US FDA

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

Antigen, Iha, T. Cruzi

FDA classification
FDA Class 1 ·Antigen, Iha, T. Cruzi

Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

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

Antigen, Galactomannan, Aspergillus Spp.

FDA classification
FDA Class 1 ·Antigen, Galactomannan, Aspergillus Spp.

Procalcitonin Assay

FDA classification
FDA Class 2 ·Procalcitonin Assay

Kit, Fastidious Organisms

FDA classification
FDA Class 1 ·Kit, Fastidious Organisms

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

Antisera, Fluorescent, All Types, Staphylococcus Spp.

FDA classification
FDA Class 1 ·Antisera, Fluorescent, All Types, Staphylococcus Spp.

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

Antisera, Fluorescent, Chlamydia Spp.

FDA classification
FDA Class 1 ·Antisera, Fluorescent, Chlamydia Spp.

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

Assay, Direct, Nucleic Acid Amplification, Q Fever

FDA classification
FDA Class 1 ·Assay, Direct, Nucleic Acid Amplification, Q Fever

System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

FDA classification
FDA Class 1 ·System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

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