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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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Boule Con-Diff Tri-Level - 00812137010216

For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
6 x 4.5mL
In Commercial Distribution

  • 00812137010216 ()
  • 00812137011794 ()
501-605

  • Full blood count IVD, control

SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit - 00812117017563

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

  • 00812117017563 ()
A15573

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit - 00812117017556

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

SeCore™ CDx HLA GSSP Kit - 00812117016825

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

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

FIT SA - E235Y25620

FIT SA F10 A3 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25620 ()
Y2562

  • Dental composite resin

FIT SA - E235Y25610

FIT SA F10 A2 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25610 ()
Y2561

  • Dental composite resin

FIT SA - E235Y25600

FIT SA F10 A1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25600 ()
Y2560

  • Dental composite resin

FIT SA - E235Y25540

FIT SA F03B1 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25540 ()
Y2554

  • Dental composite resin

FIT SA - E235Y25530

FIT SA F03A4 2.2g
SHOFU DENTAL CORPORATION
001
In Commercial Distribution

  • E235Y25530 ()
Y2553

  • Dental composite resin
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