System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

H-103 IGG, H-104 IGA, H-105 IGM

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology

AUTOMATED IMMUNOPRECIPITIN METHOD/ICG

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO RABBIT IMMUNOGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM IGG ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERA TO RABBIT IMMUNOGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM

FDA 510(k)

FDA Class 2 ·Dental

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACKS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS

Igd, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Igd, Fitc, Antigen, Antiserum, Control

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Immunoglobulin G (Igg) Infusion System

FDA classification

FDA Class 2 ·Immunoglobulin G (Igg) Infusion System

System, Electrogastrography (Egg)

FDA classification

FDA Class 2 ·System, Electrogastrography (Egg)

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS