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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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VITROS Chemistry Products dHDL Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
6802469
In Commercial Distribution

  • 10758750002825 ()
  • 20758750002822 ()
6802469

  • High density lipoprotein (HDL) cholesterol IVD, reagent
VITROS Chemistry Products dHDL Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801895
In Commercial Distribution

  • 10758750001668 ()
  • 20758750001665 ()
6801895

  • High density lipoprotein (HDL) cholesterol IVD, reagent
No Description
BIOGENEX LABORATORIES
HK606-10K
In Commercial Distribution

  • 00810119673336 ()

  • Total Volume: 1 Milliliter
HK606-10K

  • DAPI solution IVD
VITROS Chemistry Products Performance Verifier II
ORTHO-CLINICAL DIAGNOSTICS, INC.
8231474
In Commercial Distribution

  • 10758750004577 ()
8231474

  • Multiple-type clinical chemistry analyte profile IVD, control
VITROS Chemistry Products Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
8067324
In Commercial Distribution

  • 10758750004317 ()
8067324

  • Multiple-type clinical chemistry analyte profile IVD, control
VITROS Chemistry Products ALTV Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
6844288
In Commercial Distribution

  • 10758750032136 ()
  • 20758750032133 ()
6844288

  • Alanine aminotransferase (ALT) IVD, reagent
VITROS XT Chemistry Products ALTV-AST Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
6844291
In Commercial Distribution

  • 10758750031757 ()
  • 20758750031754 ()
6844291

  • Multiple-type clinical chemistry analyte profile IVD, reagent
VITROS Chemistry Products LDHI Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
6844430
In Commercial Distribution

  • 10758750031108 ()
  • 20758750031105 ()
6844430

  • Total lactate dehydrogenase (LDH) IVD, reagent
VITROS Chemistry Products CHOL Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
1669829
In Commercial Distribution

  • 10758750009527 ()
  • 20758750009524 ()
1669829

  • Total cholesterol lipid IVD, reagent
No Description
YAMAHACHI DENTAL MFG.,CO.
28,U,D4
In Commercial Distribution

  • D080SSMILXX28XUXD40 ()
  • 04582276035505 ()


  • Resin artificial teeth
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