ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

FDA 510(k)

FDA Class 2 ·Hematology

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

HOWSE II TOTAL HIP REPLACEMENT SYSTEM

FDA 510(k)

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Erythropoietin (EPO) assay

FDA 510(k)

FDA Class 2 ·Hematology

ARCHITECT Active-B12 (Holotranscobalamin)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

FDA 510(k)

FDA Class 2 ·Immunology

CRYOcheck™ Factor IX Deficient Plasma

FDA UDI

Precision Biologic Inc·00843876000305·

CRYOcheck™ Factor IX Deficient Plasma

FDA UDI

Precision Biologic Inc·00843876000312·

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

D3 Ultra Duet DFA Respiratory Virus

FDA registration

Ortho-Clinical Diagnostics, Inc.·5 products·🇺🇸 United States

663940 Immunochemistry Systems CAL 2 Calibrator 2

FDA registration

BECKMAN COULTER, INC.·7 products·🇺🇸 United States

Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/HRP

FDA UDI

AGILENT TECHNOLOGIES SINGAPORE PTE LTD·05700572007319·Polyclonal Rabbit Anti-Human IgA, IgG, IgM, Kap...

Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/FITC

FDA UDI

AGILENT TECHNOLOGIES SINGAPORE PTE LTD·05700572002468·Polyclonal Rabbit Anti-Human IgA, IgG, IgM, Kap...

Angelcup - Crystal

FDA UDI

Grupo IX Kaan, S.A. de C.V.·G391ANGCRLG2·Reusable Menstrual Cup - Large Size

Angelcup - Lilac

FDA UDI

Grupo IX Kaan, S.A. de C.V.·G391ANGLILLG2·Reusable Menstrual Cup - Large Size