25 results · 8ms · Sources: EU EUDAMED, US FDA

DSP for cobas 8100

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Hitachi High-Tech Corporation·1 device

ASP System

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EU IVDR · Eu Ivd Class A ·ASP Health Inc.·1 device

CL AIA-PACK Anti-SARS-CoV-2-SP-IgG ADJUSTER SET

Basic UDI-DI
EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

CL AIA-PACK Anti-SARS-CoV-2-SP-IgG TEST CUP

Basic UDI-DI
EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

KL-6/SP-A/SP-D/MMP-7/CCL18 Detection Kit (Flow Cytometry)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Qingdao Raisecare Biological Technology Co., Ltd.·1 device

KL-6/SP-A/SP-D/MMP-7/CCL18 Detection Kit (Flow Cytometry)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Qingdao Raisecare Biological Technology Co., Ltd.·1 device

KL-6/SP-A/SP-D/MMP-7/CCL18 Detection Kit (Flow Cytometry)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Qingdao Raisecare Biological Technology Co., Ltd.·1 device

Bilirubin Total (Bil-T) Kit (DSA Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Bilirubin Direct Kit (DSA Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR -Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·1 device

Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·1 device

HIV Rapid Test Device (Whole blood/Serum/Plasma)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

HIV 1.2 Rapid Test Cassette

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EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·1 device

HBsAg Rapid Test Cassette

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·1 device

HBsAg Rapid Test Cassette

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·1 device

HBsAg Rapid Test Cassette

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·1 device

HBsAg Rapid Test Cassette

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Hangzhou Alltest Biotech.Co.,Ltd.·1 device