8,758 results · 44ms · Sources: EU EUDAMED, US FDA

Antigens, All Groups, Salmonella Spp.

FDA classification
FDA Class 2 ·Antigens, All Groups, Salmonella Spp.

Antisera, Fluorescent, Brucella Spp.

FDA classification
FDA Class 2 ·Antisera, Fluorescent, Brucella Spp.

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

FDA classification
FDA Class 2 ·Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification
FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Antigen, Latex Agglutination, Coccidioides Immitis

FDA classification
FDA Class 2 ·Antigen, Latex Agglutination, Coccidioides Immitis

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

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