Sofia Strep A+ FIA

FDA registration

QUIDEL CORP.·1 product·🇺🇸 United States

Sofia Strep A+ FIA

FDA registration

Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

Laboratorios Scantibodies, S.A. de C.V.

FDA registration

Laboratorios Scantibodies, S.A. de C.V.·1 product·🇲🇽 Mexico

Sofia Strep A+ FIA

FDA registration

Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

LABORATORIOS SCANTIBODIES S.A. DE C.V.

FDA registration

LABORATORIOS SCANTIBODIES S.A. DE C.V.·1 product·🇲🇽 Mexico

SOFIA (R) STREP A+ FIA

FDA 510(k)

FDA Class 1 ·Microbiology

Antigens, All Groups, Streptococcus Spp.

FDA classification

FDA Class 1 ·Antigens, All Groups, Streptococcus Spp.

STERILIZATION SERVICES OF GEORGIA, INC.

FDA registration

STERILIZATION SERVICES OF GEORGIA, INC.·1 product·🇺🇸 United States

Stryker Universal Neuro 3 System

FDA registration

STRYKER LEIBINGER GMBH & CO. KG·3 products·🇩🇪 Germany

RenovoCath RC120 catheter

FDA registration

MEDICAL MURRAY, INC.·1 product·🇺🇸 United States

Prosigna(R) Breast Cancer Prognostic Gene Signature Assay

FDA registration

VERACYTE SAS·1 product·🇫🇷 France

PLAC® Test for Lp-PLA2 Activity

FDA registration

Diazyme Laboratories, Inc.·3 products·🇺🇸 United States

EliA™ M2 Immunoassay

FDA registration

PHADIA US INC.·2 products·🇺🇸 United States

GE DATEX-OHMEDA ENGSTROM CARESTATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

JBAIDS INFLUENZA A&B DETECTION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Respiratory Virus Panel Nucleic Acid Assay System

FDA classification

FDA Class 2 ·Respiratory Virus Panel Nucleic Acid Assay System

Ventilator, Continuous, Facility Use

FDA classification

FDA Class 2 ·Ventilator, Continuous, Facility Use