20 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
×
cerascreen® Dog hair Allergy Test
Device
EU IVDR
·
Eu Ivd Class A
·Cerascreen GmbH·On the market·10 countries
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
Device
EU IVDR
·
Eu Ivd Class A
·QUANTIDX HONG KONG LIMITED·On the market
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
Device
EU IVDR
·
Eu Ivd Class A
·QUANTIDX HONG KONG LIMITED·On the market
BioCLIA Autoimmune Reagent Kit dsDNA
Device
EU IVDR
·
Eu Ivd Class B
·HOB Biotech Group Corp., Ltd.·On the market·3 countries
BioCLIA System Substrate
Device
EU IVDR
·
Eu Ivd Class A
·HOB Biotech Group Corp., Ltd.·On the market·3 countries
BioCLIA System Substrate
Device
EU IVDR
·
Eu Ivd Class A
·HOB Biotech Group Corp., Ltd.·On the market·3 countries
BioCLIA System Wash Buffer
Device
EU IVDR
·
Eu Ivd Class A
·HOB Biotech Group Corp., Ltd.·On the market·3 countries
BioCLIA Sample Diluent I
Device
EU IVDR
·
Eu Ivd Class A
·HOB Biotech Group Corp., Ltd.·On the market·3 countries
Total β Human Chorionic Gonadotrophin（CLIA）、Total β HCG Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
HCG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Hubei MEIBAO Biotechnology Co., Ltd·14 devices
AUTOMATED BLOOD CULTURE ANALYSERS
Device
EU IVDR
·
Eu Ivd Class A
·Grant Technology (HK) Co., Ltd.·On the market
iFlash-Total β HCG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·SHENZHEN YHLO BIOTECH CO., LTD.·3 devices
hCG screening RIA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·IMMUNOTECH s.r.o.·1 device
Real-Time qPCR System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·QUANTIDX HONG KONG LIMITED·2 devices
Alanine Aminotransferase kit (IFCC Method)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·HOB Biotech Group Corp., Ltd.·1 device
BioCLIA Sample Diluent I,BioCLIA System Wash Buffer,BioCLIA System Substrate
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·HOB Biotech Group Corp., Ltd.·4 devices
Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Lifotronic Technology Co., Ltd.·4 devices
Bioaxon Rapid Test Dipstick ( Urine ) Pregnancy (hCG) Rapid Test Dipstick ( Urine )
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Bioaxan·1 device
Automated Blood Culture Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Grant Technology (HK) Co., Ltd.·1 device