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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™ CDx HLA A Locus Sequencing Kit - 00812117016818

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

CHANG Marrow - 00810195240576

Bone Marrow Culture Medium with Gentamicin. 500mL bottle.
IRVINE SCIENTIFIC, LLC
91031-500ML
In Commercial Distribution

  • 00810195240576 ()
91031

  • Cell culture medium IVD

CHANG Marrow - 00810195240569

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 Mitogen-Free - 00810195240545

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 - 00810195240538

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 - 00810195240521

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 - 00810195240637

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 - 00810195240620

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

  • 00810195240620 ()
T105

  • Cell culture medium IVD

CHANG Medium C Frozen Supplement (14mL) - 00810195240613

CHANG Medium C Frozen Supplement (14mL)
IRVINE SCIENTIFIC, LLC
C106-14ML
In Commercial Distribution

  • 00810195240613 ()
C106

  • Cell culture medium IVD

CHANG Amnio - 00810195240590

CHANG Amnio with Gentamicin and L-Glutamine. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99473-100ML
In Commercial Distribution

  • 00810195240590 ()
99473

  • Cell culture medium IVD
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