578 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Eu Ivd Class B
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AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device
EU IVDR
·
Eu Ivd Class B
·Zybio Inc.·Not intended for eu market
Hematology Analyzer
Device
EU IVDR
·
Eu Ivd Class B
·Zybio Inc.·On the market·1 country
NutriDetect™ 7G A ELISA
Device
EU IVDR
·
Eu Ivd Class B
·Biomerica, Inc.·On the market·1 country
Aptiva® APS IgG Reagent
Device
EU IVDR
·
Eu Ivd Class B
·Inova Diagnostics. Inc.·On the market·12 countries
Aptiva® APS IgM Controls
Device
EU IVDR
·
Eu Ivd Class B
·Inova Diagnostics. Inc.·On the market·20 countries
Aptiva® APS IgM Calibrators
Device
EU IVDR
·
Eu Ivd Class B
·Inova Diagnostics. Inc.·On the market·20 countries
Aptiva® APS IgM Reagent
Device
EU IVDR
·
Eu Ivd Class B
·Inova Diagnostics. Inc.·On the market·20 countries
Aptiva® APS IgG Controls
Device
EU IVDR
·
Eu Ivd Class B
·Inova Diagnostics. Inc.·On the market·20 countries
Aptiva® APS IgG Calibrators
Device
EU IVDR
·
Eu Ivd Class B
·Inova Diagnostics. Inc.·On the market·21 countries
AUTOMATED 3 PART HEMATOLOGY ANALYSERS
Device
EU IVDR
·
Eu Ivd Class B
·Genrui Biotech Inc.·On the market·1 country
ACCURUN Babesia Molecular Controls Kit
Device
EU IVDR
·
Eu Ivd Class B
·LGC Clinical Diagnostics, Inc.·On the market·30 countries
ISE Low Serum Standard
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
ISE High Serum Standard
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
ISE Internal Reference
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
ISE Low/High Urine Standard
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
ISE Na+/K+ Selectivity Check
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
ISE BUFFER
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
ISE MID STANDARD
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
ISE Reference
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries
Myoglobin
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·On the market·32 countries