835 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Kind: Professional Testing
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Urinary Total Protein (UTP) Assay Kit (Pyrogallol Red Molybdenum Method)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device
Protein Extraction Kit
Basic UDI-DI
EU IVDR
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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
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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
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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
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Eu Ivd Annex 2 List B
·Qingdao Hightop Biotech Co., Ltd.·1 device
Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Acon Biotech (Hangzhou) Co., Ltd.·1 device
Automatic Chemiluminescence Immunoassay Analyzer
Basic UDI-DI
EU IVDR
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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
𝝱 Ketone Test Strip
Basic UDI-DI
EU IVDD
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Eu Ivd Self Testing
·ForaCare Suisse AG·1 device
Blood Glucose Monitoring System
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·ForaCare Suisse AG·1 device
VitaSIRO solo Instrument
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device
VitaPCR Flu A&B Assay
Basic UDI-DI
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
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device
VitaPCR SARS-CoV-2 External Control Set
Basic UDI-DI
EU IVDD
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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
VitaPCR RSV External Control Set
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device