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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i HBsAg Qualitative II Reagent Kit (2x l 00 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Al

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests)

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc Reagent Kit (2x 100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests)

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

LPA400C Lipoprotein (a) Calibrator

FDA registration

HORIBA INSTRUMENTS INCORPORATED·3 products·🇺🇸 United States

Alinity c Lp(a) Reagent Kit

FDA registration

BIOKIT S.A.·3 products·🇪🇸 Spain

H7575-CTL, Pointe Homocysteine Controls

FDA registration

HORIBA INSTRUMENTS INCORPORATED·3 products·🇺🇸 United States

Carolina Liquid Chemistries Corp.

FDA registration

Carolina Liquid Chemistries Corp.·3 products·🇺🇸 United States

Caps Warmer

FDA registration

VOCO GMBH·3 products·🇩🇪 Germany

Calset Composite Warmer

FDA registration

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

AXIS SHIELD Homocysteine Control Kit (FHCY200/ B08177)

FDA registration

AXIS-SHIELD DIAGNOSTICS, LTD.·3 products·🇬🇧 United Kingdom

Quantia Lipoprotein(a) (LN 7K00-40, 7K00-41)

FDA registration

ABBOTT LABORATORIES·3 products·🇺🇸 United States

PRECISET LP (A) GEN 2 CALIFRATOR SET

FDA registration

ROCHE DIAGNOSTICS GMBH·3 products·🇩🇪 Germany

RANDOX LIPOPROTEIN A

FDA registration

RANDOX LABORATORIES LIMITED·3 products·🇬🇧 United Kingdom

AFC-330

Basic UDI-DI

EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·1 device

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core Antigen (aHBcM)

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

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

FDA Pre-Market Approval

FDA Class 3 ·BIO RAD MONOLISA ANTI-HBC IGM EIA

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc II, PreciControl Anti-HBc