IR-192 IMPLANT

FDA 510(k)

FDA Class 2 ·Radiology

BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

BioPlex 2200 25-OH Vitamin D Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IR-192 IMPLANT

FDA 510(k)

FDA Class 2 ·Radiology

Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit

FDA 510(k)

FDA Class 2 ·Dental

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS RUBELLA IGG

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Sentinel

FDA 510(k)

FDA Class 2 ·Radiology

VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS(R) TOTAL T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CATALYST

FDA 510(k)

FDA Class 2 ·Radiology

BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Catalyst+, Catalyst+ HD

FDA 510(k)

FDA Class 2 ·Radiology

BIOPLEX 2200 TORC IGG

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS(R) THYROXINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry