13 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
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AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device
EU IVDR
·
Eu Ivd Class A
·PCL Inc.·On the market
Albumin (BCG)
Device
EU IVDR
·
Eu Ivd Class B
·Thermo Fisher Scientific Oy·On the market·28 countries
PCLOK II
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·PCL Inc.·1 device
AGAR BAZA CANDIDA BCG
Device
EU IVDR
·
Eu Ivd Class A
·SC MEDICAMED MARKET SRL·On the market
Procalcitonin(CLIA)、PCT Calibrators、PCT Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices
HCG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Hubei MEIBAO Biotechnology Co., Ltd·14 devices
Albumin (BCG)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Thermo Fisher Scientific Oy·1 device
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
iFlash-Total β HCG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·SHENZHEN YHLO BIOTECH CO., LTD.·3 devices
AGAR BAZA CANDIDA BCG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·SC MEDICAMED MARKET SRL·1 device
hCG screening RIA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·IMMUNOTECH s.r.o.·1 device
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