Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

Antisera, Cf, Coxsackievirus A 1-24, B 1-6

FDA classification

FDA Class 1 ·Antisera, Cf, Coxsackievirus A 1-24, B 1-6

Antiserum, Murine Typhus Fever

FDA classification

FDA Class 1 ·Antiserum, Murine Typhus Fever

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

FDA classification

FDA Class 2 ·Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Reagent/Device, Inoculum Calibration

FDA classification

FDA Class 2 ·Reagent/Device, Inoculum Calibration

Antiserum, Cf, Epstein-Barr Virus

FDA classification

FDA Class 1 ·Antiserum, Cf, Epstein-Barr Virus

Dna-Probe, Reagents, Cryptococcal

FDA classification

FDA Class 2 ·Dna-Probe, Reagents, Cryptococcal

Enzyme Linked Immunosorbent Assay, T. Cruzi

FDA classification

FDA Class 1 ·Enzyme Linked Immunosorbent Assay, T. Cruzi

Enzyme Linked Immunoabsorbent Assay, Rotavirus

FDA classification

FDA Class 1 ·Enzyme Linked Immunoabsorbent Assay, Rotavirus

Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus

FDA classification

FDA Class 1 ·Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus

Antigen, Elisa, Cryptococcus

FDA classification

FDA Class 2 ·Antigen, Elisa, Cryptococcus

Antisera, Fluorescent, All Globulins, Shigella Spp.

FDA classification

FDA Class 2 ·Antisera, Fluorescent, All Globulins, Shigella Spp.

Dengue Serological Reagents

FDA classification

FDA Class 2 ·Dengue Serological Reagents

Antisera, All Groups, Streptococcus Spp.

FDA classification

FDA Class 1 ·Antisera, All Groups, Streptococcus Spp.

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

Antisera, C. Acnes (553, 605)

FDA classification

FDA Class 1 ·Antisera, C. Acnes (553, 605)

System, Blood Culturing

FDA classification

FDA Class 1 ·System, Blood Culturing

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