1,024 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BD DIRECTIGEN MENINGITIS COMBO TEST KIT
FDA Adverse Event
Injury
·BD DIAGNOSTICS·Product code GTJ·August 7, 2008
BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis.
FDA Recall
Terminated
·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007
BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis.
FDA Recall
Terminated
·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007
BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.
FDA Recall
Terminated
·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007
BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis.
FDA Recall
Terminated
·BD Diagnostic Systems Lee Laboratories·Product code GTJ·September 6, 2007
Antisera, All Groups, N. Meningitidis
FDA classification
FDA Class 2
·Antisera, All Groups, N. Meningitidis
GT2 HEALTHCARE SDN.BHD.
FDA registration
GT2 HEALTHCARE SDN.BHD.·1 product·🇲🇾 Malaysia
GTI MEDICAL LTD
FDA registration
GTI MEDICAL LTD·1 product·🇮🇱 Israel
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
FDA 510(k)
FDA Class 2
·Cardiovascular
Immucor GTI Diagnostics, Inc.
FDA registration
Immucor GTI Diagnostics, Inc.·5 products·🇺🇸 United States
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648213137·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648213045·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648212987·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648213120·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648212970·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648213144·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648212932·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648213052·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648212963·Absorb GT1 Bioresorbable Vascular Scaffold Syst...
ABSORB GT1
FDA UDI
ABBOTT VASCULAR INC.·08717648213069·Absorb GT1 Bioresorbable Vascular Scaffold Syst...