CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TURBOX THEOPHYLLINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

APOLIPOPROTEIN B

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ALBUMIN IN URINE

FDA 510(k)

FDA Class 2 ·Immunology

TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

CLEARPLAN EASY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALBUMIN IN SERUM

FDA 510(k)

FDA Class 2 ·Immunology

CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OXOID INFECTIOUS MONONUCLEOSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

CLEARVIEW C. DIFF A

FDA 510(k)

FDA Class 1 ·Microbiology

HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGLOBULINS M

FDA 510(k)

FDA Class 2 ·Immunology

EMULSIE GALBENUS DE OU (EGG YOLK EMULSION)

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·S.C. Sanimed International Impex SRL·1 device

Rapid 2019-nCoV IgG/IgM Combo Test Card

Device

EU IVDD · Eu Ivd General ·Xiamen Boson Biotech Co., Ltd.·On the market

Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone

Device

EU IVDR · Eu Ivd Class C ·Immucor, Inc.·On the market·32 countries

Rapid Salmonella typhi IgG/IgM Duo Test Card

Device

EU IVDD · Eu Ivd General ·Xiamen Boson Biotech Co., Ltd.·On the market

Mycoplasma pneumoniae IgG antibody Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

VALIDATE® Anti-SARS-CoV2 IgG Test Set

Device

EU IVDD · Eu Ivd General ·LGC Clinical Diagnostics, Inc.·On the market