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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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SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017556 ()
A15571

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-GSSP
In Commercial Distribution

  • 00812117016825 ()
SECCDX-GSSP

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.
ONE LAMBDA, INC.
SECCDX-A
In Commercial Distribution

  • 00812117016818 ()
SECCDX-A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Bone Marrow Culture Medium with Gentamicin. 500mL bottle.
IRVINE SCIENTIFIC, LLC
91031-500ML
In Commercial Distribution

  • 00810195240576 ()
91031

  • Cell culture medium IVD
Bone Marrow Culture Medium with Gentamicin. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91031-100ML
In Commercial Distribution

  • 00810195240569 ()
91031

  • Cell culture medium IVD
CHANG Medium MF with Gentamicin. Mitogen Free Medium for Culture of Hemopoietic Cells. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91005-100ML
In Commercial Distribution

  • 00810195240545 ()
91005

  • Cell culture medium IVD
CHANG Medium BMC Bone Marrow Culture Medium. 500mL bottle.
IRVINE SCIENTIFIC, LLC
91004-500ML
In Commercial Distribution

  • 00810195240538 ()
91004

  • Cell culture medium IVD
CHANG Medium BMC Bone Marrow Culture Medium. 100mL bottle.
IRVINE SCIENTIFIC, LLC
91004-100ML
In Commercial Distribution

  • 00810195240521 ()
91004

  • Cell culture medium IVD
CHANG Medium D with L-Glutamine. 500mL bottle.
IRVINE SCIENTIFIC, LLC
T105-500ML
In Commercial Distribution

  • 00810195240637 ()
T105

  • Cell culture medium IVD
CHANG Medium D with L-Glutamine. 100mL bottle.
IRVINE SCIENTIFIC, LLC
T105-100ML
In Commercial Distribution

  • 00810195240620 ()
T105

  • Cell culture medium IVD
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