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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Simultest IMK Plus Kit 50 Tests IVD
Becton, Dickinson And Company
349217
In Commercial Distribution

  • 00382903492176 ()
349217

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Leucocount RBC Control Kit 25 Tests IVD
BECTON, DICKINSON AND COMPANY
341001
Not in Commercial Distribution

  • 00382903410019 ()
341001

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Reagent Red Blood Cells; Biotestcell® A1 & B; 3.0 - 3.4%; pooled cells for reverse grouping by the tube test; 2x10ml
Bio-Rad Medical Diagnostics GmbH
816057100
In Commercial Distribution

  • 07611969952663 ()
816057100

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
Reagent Red Blood Cells; 1.0 - 1.3%;pooled cells for reverse grouping with the TANGO instruments; 2x10ml
Bio-Rad Medical Diagnostics GmbH
816056100
In Commercial Distribution

  • 07611969952656 ()
816056100

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled cells for reverse grouping with IH-Cards; 2 x 10 mL
Bio-Rad Medical Diagnostics GmbH
814010100
In Commercial Distribution

  • 07611969952243 ()
814010100

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
No Description
Bion Enterprises, Ltd.
QEP-6604
In Commercial Distribution

  • B110QEP66040 ()
QEP-6604

  • Multiple enterovirus antigen IVD, control
Reagent Red Blood Cells A1 and B cells formulated for the use in Beckman Coulter® PK® Systems
DIAGAST
17318
In Commercial Distribution

  • 33661562173182 ()
17318

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
No Description
Hologic, Inc.
LBL BOX, DPROBE, ULTRIO, 200T, IVD
Not in Commercial Distribution

  • 15420045504264 ()
PRD-03709

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent
No Description
Hologic, Inc.
LBL BOX, DPROBE, ULTRIO, 200T, IVD
Not in Commercial Distribution

  • 15420045504257 ()
PRD-03708

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent
BD Multitest™ 6-Color TBNK with BD Trucount™ Tubes
Becton, Dickinson And Company
662995
In Commercial Distribution

  • 00382906629951 ()
662995

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
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