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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 - 10758750002351

VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802241
In Commercial Distribution

  • 10758750002351 ()
  • 20758750002358 ()
6802241

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001323

VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801758
In Commercial Distribution

  • 10758750001323 ()
  • 20758750001320 ()
6801758

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750000548

VITROS Immunodiagnostic Products CA 125 II Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800034
In Commercial Distribution

  • 10758750000548 ()
  • 20758750000545 ()
6800034

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

IRISpec - 10837461002611

IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS
BECKMAN COULTER IRELAND INC.
CA/CB/CC URINE CHEMSITRY CONTROLS
In Commercial Distribution

  • 10837461002611 ()
800-7211

  • Multiple urine analyte IVD, control

H4 - 00840273920984

H4 .022 U HKS 345 7X7 CA
World Class Technology Corporation
916.2152
In Commercial Distribution

  • 00840273920984 ()
916.2152

  • Orthodontic bracket, metal

H4 - 00840273920977

H4 .022 L HKS 345 7X7 CA
World Class Technology Corporation
916.2151
In Commercial Distribution

  • 00840273920977 ()
916.2151

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273915836

Roth .018 HKS 3, 4, CA LRGTRAY
World Class Technology Corporation
905.1031-LRGTRAY
In Commercial Distribution

  • 00840273915836 ()
905.1031-LRGTRAY

  • Orthodontic bracket, metal

BioMIM Mini Twin Brackets - 00840273916703

Roth .022 HKS 3, 4, CA LRGTRAY
World Class Technology Corporation
905.2031-LRGTRAY
In Commercial Distribution

  • 00840273916703 ()
905.2031-LRGTRAY

  • Orthodontic bracket, metal

Alinity - 00380740146603

Alinity i CA 125 II Assay File
Abbott GmbH
08P491A
In Commercial Distribution

  • 00380740146603 ()
08P491A

  • Laboratory instrument/analyser application software IVD

Medline - 10888277388420

277-10-418 FAST CTNG MICRO BUR,RND,CA
MEDLINE INDUSTRIES, INC.
27710418RH
In Commercial Distribution

  • 10888277388420 ()
27710418RH

  • Orthopaedic bur, single-use
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