Antisera, If, Toxoplasma Gondii

FDA classification

FDA Class 2 ·Antisera, If, Toxoplasma Gondii

Positive Blood Culture Identification And Ast Kit

FDA classification

FDA Class 2 ·Positive Blood Culture Identification And Ast Kit

Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

FDA classification

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

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

Dna-Probe, Reagents, Cryptococcal

FDA classification

FDA Class 2 ·Dna-Probe, Reagents, Cryptococcal

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

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

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification

FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology