COAGULATION INTRINSIC DEFICIENT PLASMAS

FDA 510(k)

FDA Class 2 ·Hematology

CALIBRATION REFERENCE PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

VON WILLEBRAND REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

REFACTO LABORATORY STANDARD

FDA 510(k)

FDA Class 2 ·Hematology

SPECTRO C

FDA 510(k)

FDA Class 2 ·Hematology

VON WILLEBRAND FACTOR ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

TINTELIZE PAI-1 KIT

FDA 510(k)

FDA Class 2 ·Hematology

HELENA FACTOR X DEFICIENT SUBSTRATE

FDA 510(k)

FDA Class 2 ·Hematology

ASSERA PLATE IX:AG KIT

FDA 510(k)

FDA Class 2 ·Hematology

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS

Freezing embedding medium

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·WellMed BV·1 device

Apex Lite 4 Wheel

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Pride Mobility Products Corporation·1 device

Sharay Anti-DGP IgG (CLIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·1 device

Sharay Anti-DGP IgA (CLIA)

Basic UDI-DI

EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·1 device

Anti Deamidated Gliadin Peptide (DGP) IgA

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Dia.Metra Srl·1 device

Anti Deamidated Gliadin Peptide (DGP) IgG

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Dia.Metra Srl·1 device

BioCLIA Autoimmune Control Set, DGP IgG

Basic UDI-DI

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·1 device