Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

CSM-BC400-L

FDA registration

RONDISH COMPANY LIMITED·1 product·🇭🇰 Hong Kong

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM HAVAB-M 2.0

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-EBK PLUS ASSAY

Tablo® Hemodialysis System

FDA registration

Outset Medical, Inc.·3 products·🇺🇸 United States

Moda-flx Hemodialysis System

FDA registration

DIALITY, INC.·3 products·🇺🇸 United States

U9000 Ultrafilter

FDA registration

VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE LIMITED·3 products·🇮🇳 India

Tablo® Hemodialysis System

FDA registration

Baja Fur S.A. de C.V.·3 products·🇲🇽 Mexico

U9000 Ultrafilter

FDA registration

GAMBRO DIALYSATOREN GMBH·3 products·🇩🇪 Germany

Tablo® Hemodialysis System

FDA registration

Baja Fur S.A. de C.V.·3 products·🇲🇽 Mexico

U9000 Ultrafilter

FDA registration

Vantive US Healthcare LLC·3 products·🇺🇸 United States

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR

V8800 Critical Care Ventilator

FDA registration

BEIJING AEONMED CO., LTD.·4 products·🇨🇳 China

SentrySuite Product Line 2.7

FDA registration

Jaeger Medical GmbH·4 products·🇩🇪 Germany