Device, Specimen Collection

FDA classification

FDA Class 1 ·Device, Specimen Collection

Antigen, Bentonite Flocculation, Trichinella Spiralis

FDA classification

FDA Class 1 ·Antigen, Bentonite Flocculation, Trichinella Spiralis

Antiserum, Fluorescent, Q Fever

FDA classification

FDA Class 1 ·Antiserum, Fluorescent, Q Fever

Dna-Probe, Agent, Listeria

FDA classification

FDA Class 1 ·Dna-Probe, Agent, Listeria

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