23 results
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58ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOLYTICAL LABORATORIES INC.
FDA registration
BIOLYTICAL LABORATORIES INC.·2 products·🇨🇦 Canada
HIV-1 Control Test Kit
FDA UDI
Biolytical Laboratories Inc·06865979010306·HIV-1 Control Test Kit
INSTI HIV Self Test
FDA UDI
Biolytical Laboratories Inc·00686597201725·The INSTI HIV Self Test is a single use, rapid,...
INSTI HIV-1/HIV-2 Control Test Kit
FDA UDI
Biolytical Laboratories Inc·00686597010310·INSTI HIV-1/HIV-2 Control Test Kit
INSTI Test Controls HIV-1
FDA UDI
Biolytical Laboratories Inc·06865978010710·INSTI Test Controls HIV-1
INSTI HIV-1/HIV-2 Antibody Test
FDA UDI
Biolytical Laboratories Inc·06865979010191·Single-use rapid assay for the detection of ant...
INSTI HIV-1/HIV-2 Test Controls
FDA UDI
Biolytical Laboratories Inc·06865978010376·INSTI HIV-1/HIV-2 Test Controls
INSTI HIV-1/HIV-2 Antibody Test
FDA UDI
Biolytical Laboratories Inc·06865979010207·24 tests without support material
INSTI HIV-1/HIV-2 Control Test
FDA UDI
Biolytical Laboratories Inc·06865979010313·INSTI HIV-1/HIV-2 Control Test
INSTI HIV-1/HIV-2 Antibody Test
FDA UDI
Biolytical Laboratories Inc·00686597010198·Single-use rapid assay for the detection of ant...
INSTI HIV-1/HIV-2 Antibody Test
FDA UDI
Biolytical Laboratories Inc·06865979010184·24 Tests with support materials
INSTI HIV-1 Control Test Kit
FDA UDI
Biolytical Laboratories Inc·00686597010303·INSTI HIV-1 Control Test Kit
INSTI HIV-1/HIV-2 ANTIBODY TEST
FDA Adverse Event
Malfunction
·BIOLYTICAL LABORATORIES INC.·Product code MZF·February 28, 2017
INSTI
FDA Adverse Event
Malfunction
·BIOLYTICAL LABORATORIES INC.·Product code MZF·August 11, 2015
INSTI HIV-1/HIV-2 ANTIBODY TEST
FDA Adverse Event
Malfunction
·BIOLYTICAL LABORATORIES INC·Product code MZF·May 17, 2021
INSTI HIV-1/HIV-2 ANTIBODY TEST
FDA Adverse Event
Malfunction
·BIOLYTICAL LABORATORIES INC·Product code MZF·May 17, 2021
HIV TEST KIT
FDA Adverse Event
Other
·BIOLYTICAL LABORATORIES INC.·Product code MZF·January 3, 2014
INSTI HIV-1/HIV-2 ANTIBODY TEST
FDA Adverse Event
Injury
·BIOLYTICAL LABORATORIES INC.·Product code MZF·July 5, 2018
INSTI HIV-1/HIV-2 ANTIBODY TEST
FDA Adverse Event
Malfunction
·BIOLYTICAL LABORATORIES INC·Product code QSU·December 21, 2023
INSTI HIV-1/HIV-2 ANTIBODY TEST
FDA Adverse Event
Injury
·BIOLYTICAL LABORATORIES INC.·Product code MZF·July 5, 2018