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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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Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-01
In Commercial Distribution

  • M90107RD7061011 ()
  • M90107RD7061010 ()

  • Length: 75 Millimeter
07RD7061-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Bion Enterprises, Ltd.
QRP-6314
Not in Commercial Distribution

  • B110QRP63140 ()
QRP-6314

  • Multiple-genus respiratory virus antigen IVD, control
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

  • 00812117012582 ()
LCT1W60

  • 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
No Description
AALTO SCIENTIFIC
K898M-5
In Commercial Distribution

  • B085K898M50 ()


  • Multiple urine analyte IVD, control
No Description
AALTO SCIENTIFIC
K897M-5
In Commercial Distribution

  • B085K897M50 ()


  • Multiple urine analyte IVD, control
AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
ADVIN BIOTECH, INC.
PPCup-14-01
In Commercial Distribution

  • 00840050517536 ()
  • 10840050517533 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50
ADVIN BIOTECH, INC.
PPCup-12-71
In Commercial Distribution

  • 10840050517526 ()
  • 00840050517529 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI300/THC50
ADVIN BIOTECH, INC.
PPCup-06-67
In Commercial Distribution

  • 10840050517519 ()
  • 00840050517512 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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