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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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AllSet+™ Gold SSP B*08 High Resolution Kit - 00814695022090

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022090 ()
541180D

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

AllSet+™ Gold SSP B*27 High Resolution Kit - 00814695022076

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022076 ()
541160D

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

AllSet+™ Gold SSP B Locus High Resolution Kit - 00812117017839

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017839 ()
54020D

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

LABType™ HD Class I B Locus Typing Test - 00812117014579

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014579 ()
RSSOH1B

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

LABType™ SSO Class I B Locus Typing Test - 00812117011059

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011059 ()
RSSO1B

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

Lambda Monoclonal Trays™ Set HLA Class I (B) - 00812117010274

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010274 ()
LM144B

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

Terasaki HLA Class I ABC Tissue Typing Tray - (B) - 00812117010151

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010151 ()
TS144B

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

Terasaki HLA Class I Tissue Typing Tray Set (B) - 00812117010137

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010137 ()
TM144B

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

StimQ Freedom-8A Trial Kit Channel B US w/ Receiver - 00818225020785

StimQ Peripheral Nerve Stimulator System
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-TRL-B0
In Commercial Distribution

  • 00818225020785 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system

Atos Medical - 00817126020894

2010-064 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/55 and Provox® Adhesives
ATOS MEDICAL INC.
2010-064
Not in Commercial Distribution

  • 00817126020894 ()
2010-064

  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostomy tube neck holder, reusable
  • Airway device cleaning utensil, noninvasive, reusable
  • In vitro ultraviolet blood irradiator
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