603 results · 41ms · Sources: EU EUDAMED, US FDA

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

FDA classification
FDA Class 2 ·Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

Trichomonas Vaginalis Nucleic Acid Amplification Test System

FDA classification
FDA Class 2 ·Trichomonas Vaginalis Nucleic Acid Amplification Test System

Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

FDA classification
FDA Class 2 ·Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

Antiserum, Positive And Negative Febrile Antigen Control Serum

FDA classification
FDA Class 2 ·Antiserum, Positive And Negative Febrile Antigen Control Serum

Assay, Enterovirus Nucleic Acid

FDA classification
FDA Class 2 ·Assay, Enterovirus Nucleic Acid

Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus

FDA classification
FDA Class 1 ·Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus

Investigational Use Only - Microbiology

FDA classification
FDA Not Classified ·Investigational Use Only - Microbiology

Antigens (Febrile), Agglutination, Brucella Spp.

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

Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

FDA classification
FDA Unclassified ·Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Antigen, Cf, T. Cruzi

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

C. Difficile Toxin Gene Amplification Assay

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

Device, Microtiter Diluting/Dispensing

FDA classification
FDA Class 1 ·Device, Microtiter Diluting/Dispensing

Direct Blood Bacterial Nucleic Acid Detection System

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

Antigen, Latex Agglutination, T. Cruzi

FDA classification
FDA Class 1 ·Antigen, Latex Agglutination, T. Cruzi

Antisera, Cf, Adenovirus 1-33

FDA classification
FDA Class 1 ·Antisera, Cf, Adenovirus 1-33

Antiserum, Fluorescent, Mycobacterium Tuberculosis

FDA classification
FDA Class 1 ·Antiserum, Fluorescent, Mycobacterium Tuberculosis

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