456 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Kind: Microbial Substances
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Diluent-2
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Human Gesellschaft für Biochemica und Diagnostica mbH·1 device
Diluent
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Human Gesellschaft für Biochemica und Diagnostica mbH·1 device
Chlamydia Rapid Test
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Shanghai Chemtron Biotech Co., Ltd.·1 device
One-Step FSH Menopause Test
Basic UDI-DI
EU IVDD
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Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
One-Step LH Ovulation Test
Basic UDI-DI
EU IVDD
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Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
One-Step HCG Pregnancy Test
Basic UDI-DI
EU IVDD
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Eu Ivd Self Testing
·Shanghai Chemtron Biotech Co., Ltd.·1 device
Procalcitonin(CLIA)、PCT Calibrators、PCT Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices
Liver Fibrosis Multi Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices
Insulin(CLIA)、Insulin Calibrators
Basic UDI-DI
EU IVDR
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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
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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
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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
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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
Pepsinogen I （CLIA）、PGⅠCalibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Squamous Cell Carcinoma Antigen （CLIA）、SCCA Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Carbohydrate Antigen 19-9 (CLIA)、CA19-9 Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
HBV RealQuant™ PCR
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·General Biologicals Corporation·1 device