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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...