Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Cobas TaqMan HCV Test, v2.0

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV) Assay

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·OraQuick HCV Rapid Antibody Test

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HBV CALIBRATOR KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS

Dna-Reagents, Legionella

FDA classification

FDA Class 2 ·Dna-Reagents, Legionella

Norovirus Serological Reagent

FDA classification

FDA Class 2 ·Norovirus Serological Reagent

Antigens, All Groups, Shigella Spp.

FDA classification

FDA Class 2 ·Antigens, All Groups, Shigella Spp.

Antigen, Cf (Including Cf Control), Cytomegalovirus

FDA classification

FDA Class 2 ·Antigen, Cf (Including Cf Control), Cytomegalovirus

Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

FDA classification

FDA Class 2 ·Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Human Metapneumovirus (Hmpv) Rna Assay System

FDA classification

FDA Class 2 ·Human Metapneumovirus (Hmpv) Rna Assay System

Antiserum, Vibrio Cholerae, All Varieties

FDA classification

FDA Class 2 ·Antiserum, Vibrio Cholerae, All Varieties

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

FDA classification

FDA Class 2 ·Influenza A Virus Subtype Differentiation Nucleic Acid Assay

Rickettsia Spp. Nucleic Acid Based Detection Assay

FDA classification

FDA Class 2 ·Rickettsia Spp. Nucleic Acid Based Detection Assay

Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae

FDA classification

FDA Class 2 ·Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae

Multiplex Nucleic Acid Detection System For Biothreat Agents

FDA classification

FDA Class 2 ·Multiplex Nucleic Acid Detection System For Biothreat Agents

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

FDA classification

FDA Class 2 ·Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Gram-Negative Bacteria And Associated Resistance Markers

FDA classification

FDA Class 2 ·Gram-Negative Bacteria And Associated Resistance Markers

Anti-Human Globulin, Fta-Abs Test

FDA classification

FDA Class 2 ·Anti-Human Globulin, Fta-Abs Test