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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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96 well ELISA for the detection of Anti-B2-Glycoprotein I IgG antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA22
Not in Commercial Distribution

  • 00816879020229 ()


  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018843 ()
LS1A04S

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018713 ()
LATP240

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018690 ()
LATP140X2

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018645 ()
LATM120P

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018621 ()
LATM10SA

  • HLA class I & II antibody screening IVD, kit, multiplex
The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018553 ()
LAT140S

  • HLA class I & II antibody screening IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015231 ()
LS-AB2

  • HLA class I & II antibody screening IVD, kit, multiplex
Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015170 ()
LCT1W72

  • HLA class I & II antibody screening IVD, kit, multiplex
Used in sera screening for determining the presence of serum HLA alloantibodies for HLA Class I and II specificities with a complement dependent microlymphocytotoxic assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012568 ()
LCT1W30

  • HLA class I & II antibody screening IVD, kit, multiplex
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