QUANTIMETRIC PLUS C3 REAGENT KIT

FDA 510(k)

FDA Class 2 ·Immunology

OPUS FERRITIN TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-GM & ANTI-KM TYPING SERUMS

FDA 510(k)

FDA Class 2 ·Immunology

MONICA IF24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)

FDA 510(k)

FDA Class 2 ·Orthopedic

MONICA AN24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)

FDA 510(k)

FDA Class 2 ·Orthopedic

TRIPORE, MODELS HA, BP90, BP15

FDA 510(k)

FDA Class 2 ·Orthopedic

si-Mochi

FDA 510(k)

FDA Class 2 ·Orthopedic

MONICA NOVII WIRELESS PATCH SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MONICA AN24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF

FDA 510(k)

FDA Class 2 ·Neurology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

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

Ige, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ige, Antigen, Antiserum, Control

Iga, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Iga, Antigen, Antiserum, Control

Igd, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Igd, Antigen, Antiserum, Control

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

Iga, Fitc, Antigen, Antiserum, Control

FDA classification

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