76 results · 17ms · Sources: EU EUDAMED, US FDA

Serum protein control abnormal

Basic UDI-DI
EU IVDD · Eu Ivd General ·Seleo S.r.l.·1 device

Hematoxylin and Eosin (H&E) stain

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

Papanicolaou Stain

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Tianjin Bai Lixin Bio-tech Co., Ltd.·1 device

U-TOP™ MSI Detection Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·SEASUN BIOMATERIALS Inc.·1 device

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

SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class D ·Jiangsu Medomics Medical Technology Co.,Ltd.·4 devices

COVID-19 and Influenza A/B Antigen Test Kit for self-testing

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech 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

Rapid SARS-CoV-2&Flu A&Flu B Antigen Test (Colloidal Gold)/ Nasal Swab

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Suny (Xiamen) Biotechnology Co., Ltd.·1 device

HIV 1.2 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

HBsAg Rapid Test Cassette

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

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device