260 results
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41ms
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Sources: EU EUDAMED, US FDA
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
FDA Enforcement
Class II
·Terminated·Intio Inc·March 27, 2013
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
FDA Recall
Terminated
·Intio Inc·Product code LLZ·February 26, 2013
INTIN Inc.
Manufacturer
🇰🇷 South Korea
InBios International, Inc.
Manufacturer
🇺🇸 United States·1 Importer
INBIOS INTERNATIONAL, INC.
FDA registration
INBIOS INTERNATIONAL, INC.·16 products·🇺🇸 United States
COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (1 set)
FDA UDI
INBIOS INTERNATIONAL, INC·B379RCFPCK21·
COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (10 sets)
FDA UDI
INBIOS INTERNATIONAL, INC·B379RCFPCK101·
Inito InTemp Basal Thermometer
FDA UDI
Inito Health, Inc.·00860015673107·InTemp Basal Thermometer is a device used to in...
SCoV-2 Detect™ Neutralizing Ab ELISA
FDA UDI
INBIOS INTERNATIONAL, INC·B379COVNE1·
COVID/Flu A&B RespiraDXTM Rapid Self-Test
FDA UDI
INBIOS INTERNATIONAL, INC·B379RCFS21·
Active Anthrax Detect Plus Rapid Test
FDA UDI
INBIOS INTERNATIONAL, INC·B379AAP11·
Smart DetectTM SARS-CoV-2 rRT-PCR Kit
FDA UDI
INBIOS INTERNATIONAL, INC·B379COV2E0·EUA
COVID/Flu A&B RespiraDXTM Rapid Test
FDA UDI
INBIOS INTERNATIONAL, INC·B379RCFP251·
SCoV-2 Ag Detect™ Rapid Self-Test
FDA UDI
INBIOS INTERNATIONAL, INC·B379CAGS21·
SCoV-2 Ag Detect™ Rapid Test
FDA UDI
INBIOS INTERNATIONAL, INC·B379COVAF201·POC COVID-19 antigen test, 20 tests/kit
SCoV-2 Detect™ IgG ELISA
FDA UDI
INBIOS INTERNATIONAL, INC·B379COVEG1·
COVID/Flu A&B RespiraDXTM Rapid Self-Test
FDA UDI
INBIOS INTERNATIONAL, INC·B379RCFS41·
Strongy DetectTM IgG ELISA
FDA UDI
INBIOS INTERNATIONAL, INC·B379STNG11·
SCoV-2 Detect™ IgM ELISA
FDA UDI
INBIOS INTERNATIONAL, INC·B379COVEM1·
West Nile Detect IgM Capture ELISA
FDA UDI
INBIOS INTERNATIONAL, INC·B379WNMS11·