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

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EU IVDD · Eu Ivd Annex 2 List A ·Atlas Medical GmbH·1 device

ST AIA-PACK D-Dimer CALIBRATOR SET

Basic UDI-DI

EU IVDD · Eu Ivd General ·Tosoh Corporation·1 device

Apolipoprotein A1 Kit (Turbidimetry Method)

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EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

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

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

CMV Cytomegalovirus Antibody IgM Rapid Test Kit(Colloidal Gold)

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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

Smart Pro Blood Glucose/Ketone/Uric Acid Analyzer

Basic UDI-DI

EU IVDD · Eu Ivd General ·Acon Biotech (Hangzhou) Co., Ltd.·1 device

Automatic Chemiluminescence Immunoassay Analyzer

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

Wash Reagent

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

Substrate Module

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

𝝱 Ketone Test Strip

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·ForaCare Suisse AG·1 device

Blood Glucose Monitoring System

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·ForaCare Suisse AG·1 device

VitaSIRO solo Instrument

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EU IVDR · Eu Ivd Class A ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·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

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

VitaPCR SARS-CoV-2 Assay

Basic UDI-DI

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