9,234 results · 43ms · Sources: EU EUDAMED, US FDA

Dengue Serological Reagents

FDA classification
FDA Class 2 ·Dengue Serological Reagents

Fungal Organisms, Nucleic Acid-Based Assay

FDA classification
FDA Class 2 ·Fungal Organisms, Nucleic Acid-Based Assay

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

FDA classification
FDA Class 2 ·Non-Sars Coronavirus Multiplex Nucleic Acid Assay

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification
FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

FDA classification
FDA Class 2 ·Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Assay, Genotyping, Hepatitis C Virus

FDA classification
FDA Class 2 ·Assay, Genotyping, Hepatitis C Virus

Manual Antimicrobial Susceptibility Test Systems

FDA classification
FDA Class 2 ·Manual Antimicrobial Susceptibility Test Systems

Candida Species Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Candida Species Nucleic Acid Detection System

System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

FDA classification
FDA Class 2 ·System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Antisera, Cf, Rubella

FDA classification
FDA Class 2 ·Antisera, Cf, Rubella

Antisera, Fluorescent, Human Metapneumovirus

FDA classification
FDA Class 2 ·Antisera, Fluorescent, Human Metapneumovirus

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA classification
FDA Class 2 ·Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Latex Agglutination Assay, Rubella

FDA classification
FDA Class 2 ·Latex Agglutination Assay, Rubella

Assayed Quality Control Material For Clinical Microbiology Assays

FDA classification
FDA Class 2 ·Assayed Quality Control Material For Clinical Microbiology Assays

Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae

FDA classification
FDA Class 2 ·Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae

Culture Media, For Isolation Of Pathogenic Neisseria

FDA classification
FDA Class 2 ·Culture Media, For Isolation Of Pathogenic Neisseria

Legionella, Spp., Elisa

FDA classification
FDA Class 2 ·Legionella, Spp., Elisa

Antisera, Fluorescent Antibody For Fta-Abs Test

FDA classification
FDA Class 2 ·Antisera, Fluorescent Antibody For Fta-Abs Test

Antiserum, Fluorescent, Rabies Virus

FDA classification
FDA Class 2 ·Antiserum, Fluorescent, Rabies Virus

Antigen, Positive Control, Cryptococcus Neoformans

FDA classification
FDA Class 2 ·Antigen, Positive Control, Cryptococcus Neoformans