23andMe BRCA1/BRCA2 (Selected Variants) Report

FDA registration

23ANDME, INC.·1 product·🇺🇸 United States

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

Cancer Predisposition Risk Assessment System

FDA classification

FDA Class 2 ·Cancer Predisposition Risk Assessment System

Cholesterol2 (ARCHITECT, LN 04S9230 and 04S9220 )

FDA registration

ABBOTT IRELAND DIAGNOSTICS DIVISION·1 product·🇮🇪 Ireland

Surgical face mask

FDA registration

QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD·1 product·🇨🇳 China

Level 1 / Level 3 Medical Masks

FDA registration

JMU DENTAL, INC·1 product·🇺🇸 United States

Cholesterol2 (ARCHITECT, LN 04S9230 and 04S9220 )

FDA registration

ABBOTT GmbH·1 product·🇩🇪 Germany

Cholesterol2 (ARCHITECT, LN 04S9230 and 04S9220 )

FDA registration

ABBOTT LABORATORIES·1 product·🇺🇸 United States

CARGUS INT'L, INC.

FDA registration

CARGUS INT'L, INC.·1 product·🇺🇸 United States

GLOBAL CAP CTA

FDA UDI

DEPUY ORTHOPAEDICS, INC.·10603295105633·GLOBAL C.A.P. CTA CTA THREADED PIN 6 IN

WS-140P

FDA registration

NIHON KOHDEN CORP.·4 products·🇯🇵 Japan

SARS-CoV-2 & Influenza A/B for use on the Liat System

FDA registration

ROCHE DIAGNOSTICS INTERNATIONAL LTD.·1 product·🇨🇭 Switzerland

WS-140P

FDA registration

NIHON KOHDEN AMERICA, INC.·4 products·🇺🇸 United States

ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

TRUECPR COACHING DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aid, Cardiopulmonary Resuscitation

FDA classification

FDA Class 2 ·Aid, Cardiopulmonary Resuscitation

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

FDA classification

FDA Class 2 ·Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)