1,901 results · 10ms · Sources: EU EUDAMED, US FDA

ST AIA-PACK FER

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

One Step Amphetamine (AMP) Test Kit(Hair) (Colloidal Gold )

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EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

One Step Methylenedioxymethamphetamine (MDMA) Test Device (Hair) (Immunofluorescence )

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EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

One Step Morphine (MOP) Test Device(Hair) (Immunofluorescence )

Basic UDI-DI
EU IVDD · Eu Ivd General ·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device

HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

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

HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

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

Chlamydia Rapid Test

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

One-Step FSH Menopause Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shanghai Chemtron Biotech Co., Ltd.·1 device

One-Step LH Ovulation Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shanghai Chemtron Biotech Co., Ltd.·1 device

One-Step HCG Pregnancy Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shanghai Chemtron Biotech Co., Ltd.·1 device

Procalcitonin(CLIA)、PCT Calibrators、PCT Control

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EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

Liver Fibrosis Multi Control

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EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Insulin(CLIA)、Insulin Calibrators

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

Carbohydrate Antigen 242(CLIA)、CA 242 Calibrators

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

Immunoassay Multi Control

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

HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

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

Herpes Simplex Virus 1+2 IgM(CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Herpes Simplex Virus 1+2 IgG(CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Herpes Simplex Virus-2 IgG(CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Tumor Marker Control II

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices