218 results
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46ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SD BIOSENSOR, INC.
FDA registration
SD BIOSENSOR, INC.·7 products·🇰🇷 South Korea
SD Biosensor, Inc.
FDA registration
SD Biosensor, Inc.·7 products·🇰🇷 South Korea
SD GlucoNavii Blood Glucose Monitoring System
FDA UDI
SD Biosensor, Inc.·00887473000009·
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile
FDA UDI
SD Biosensor, Inc.·00887473000290·
SD GlucoNavii Blood Glucose Monitoring System
FDA UDI
SD Biosensor, Inc.·00887473000108·
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile
FDA UDI
SD Biosensor, Inc.·00887473000306·
SD GlucoNavii Blood Glucose Monitoring System
FDA UDI
SD Biosensor, Inc.·00887473000016·
STANDARD™ LipidoCare Analyzer
FDA UDI
SD Biosensor, Inc.·00887473000283·
SD GlucoNavii Blood Glucose Test Strip
FDA UDI
SD Biosensor, Inc.·00887473000122·
STANDARD™ LipidoCare Analyzer
FDA UDI
SD Biosensor, Inc.·00887473000320·
SD GlucoNavii Blood Glucose Test Strip
FDA UDI
SD Biosensor, Inc.·00887473000160·
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile
FDA UDI
SD Biosensor, Inc.·00887473000344·
CURO L7 Analyzer
FDA UDI
SD Biosensor, Inc.·08809319396161·
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile
FDA UDI
SD Biosensor, Inc.·00887473000337·
CURO L7 Lipid Test Strip - Lipid Profile
FDA UDI
SD Biosensor, Inc.·08809319396512·
SD Glucose Control Solution
FDA UDI
SD Biosensor, Inc.·00887473000139·
FLOQSWAB
FDA Adverse Event
Malfunction
·COPAN FLOCK TECHNOLOGIES SRL·Product code KXG·May 27, 2019
FLOQSWAB
FDA Adverse Event
Malfunction
·COPAN FLOCK TECHNOLOGIES SRL·Product code KXG·May 17, 2019
FLOQSWAB
FDA Adverse Event
Malfunction
·COPAN FLOCK TECHNOLOGIES SRL·Product code KXG·June 12, 2019
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Recall
Open, Classified
·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·January 31, 2022