823 results · 9ms · Sources: EU EUDAMED, US FDA

HISTOLS-Rezisztens AEC

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Histopathology Ltd.·2 devices

ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-AB (1/256), Anti-D (1/64)), 4x10ml/carton Box

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Atlas Medical GmbH·1 device

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·1 device

Vaginal pH Test Device

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

OnSite HIV 1/2 Ab Plus Combo Rapid Test

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

Protein Extraction Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Beijing Hotgen Biotech Co., Ltd.·1 device

CMV Cytomegalovirus Antibody IgM Rapid Test Kit(Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

CMV Cytomegalovirus Antibody IgM/IgG Rapid Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

Glycosylated Hemoglobin Hemolytic Agent

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Hotgen (Langfang) Biotech Co., Ltd.·1 device

Wash Reagent

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Hotgen (Langfang) Biotech Co., Ltd.·4 devices

Substrate Module

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Hotgen (Langfang) Biotech Co., Ltd.·3 devices

Blood Glucose Monitoring System

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ForaCare Suisse AG·1 device

VitaPCR Flu A&B Assay

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EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR Strep A Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR SARS-CoV-2 Assay

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EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR SARS-CoV-2 External Control Set

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR SARS-CoV-2 Gen 2 Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR SARS-CoV-2 Gen2 External Control Set

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device