ROCHE DIAGNOSTICS CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI

FDA 510(k)

FDA Class 2 ·Hematology

ELECSYS INSULIN CALSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CALIBRATOR FOR AUTOMATED SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS DHEA-S CALCHECK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C

FDA 510(k)

FDA Class 2 ·Hematology

ELECSYS CA 125 II CALSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS ANTI-TPO CALCHECK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ELECSYS FSH CALSET II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URISYS 2400 URINE TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Physicool Combi Pack

FDA registration

PHYSICOOL LTD·1 product·🇬🇧 United Kingdom

UNIPHAR LOGISTICS

FDA registration

UNIPHAR LOGISTICS·1 product·🇺🇸 United States

Niagara Therapy Thermo Cyclopad

FDA registration

CT Healthcare Pty Ltd trading as Niagara Therapy·1 product·🇦🇺 Australia

Flex-Lite

FDA registration

FLEXIBLE TECHNOLOGIES, LLC·1 product·🇺🇸 United States

MDRS, LLC

FDA registration

MDRS, LLC·1 product·🇺🇸 United States

STRABO Glasses

FDA registration

SHENZHEN CALISON TECHNOLOGY CO., LIMITED·1 product·🇨🇳 China