THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4

FDA 510(k)

FDA Class 2 ·Immunology

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TURBOX THEOPHYLLINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

APOLIPOPROTEIN B

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ALBUMIN IN URINE

FDA 510(k)

FDA Class 2 ·Immunology

TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

CLEARPLAN EASY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALBUMIN IN SERUM

FDA 510(k)

FDA Class 2 ·Immunology

CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OXOID INFECTIOUS MONONUCLEOSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

CLEARVIEW C. DIFF A

FDA 510(k)

FDA Class 1 ·Microbiology

HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGLOBULINS M

FDA 510(k)

FDA Class 2 ·Immunology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, CP, and CP with SmartAssist

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 System