VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Device

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

VIROLOGY - NA REAGENTS - OTHER

Device

EU IVDD · Eu Ivd General ·Daan Gene Co., Ltd.·On the market

ALDOSTERONE

Device

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·On the market·32 countries

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

Device

EU IVDD · Eu Ivd General ·BioDetect（Xiamen）Biotechnology Co., Ltd.·On the market

VITAMIN B12

Device

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·On the market·32 countries

SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Analysis Software for PCR-Fluorescence Detection Data

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Aldosterone Chemiluminescent Immunoassay Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Detection Kit for 2019-nCoV (PCR-Fluorescence)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Daan Gene Co., Ltd.·1 device

cobas IGRA SARS-CoV-2 Tubes

Basic UDI-DI

EU IVDD · Eu Ivd General ·Invitros Co., Ltd·1 device

Eclipse PLUS

Device

EU IVDD · Eu Ivd General ·Apex Biotechnology Corp.·No longer on the market

GlucoSure POC

Device

EU IVDD · Eu Ivd General ·Apex Biotechnology Corp.·No longer on the market

GlucoSure POC Compact

Device

EU IVDD · Eu Ivd General ·Apex Biotechnology Corp.·No longer on the market

Eclipse A1C

Device

EU IVDD · Eu Ivd General ·Apex Biotechnology Corp.·No longer on the market

KETOSURE POC

Device

EU IVDD · Eu Ivd General ·Apex Biotechnology Corp.·On the market

KETOSURE POC

Device

EU IVDD · Eu Ivd General ·Apex Biotechnology Corp.·On the market

KETOSURE POC

Device

EU IVDD · Eu Ivd General ·Apex Biotechnology Corp.·On the market

CERA-STAT™ CRP Test Kit

Device

EU IVDD · Eu Ivd General ·GC MEDIS Corp.·On the market

CERA-STAT™ 4000 Analyzer

Device

EU IVDD · Eu Ivd General ·GC MEDIS Corp.·On the market