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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No Description
Roche Diagnostics GmbH
11776193122
In Commercial Distribution

  • 04015630904297 ()
11776193122

  • Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
07027001190
In Commercial Distribution

  • 04015630939961 ()
07027001190

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
07026986190
In Commercial Distribution

  • 04015630939633 ()
07026986190

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Biotyper system for clinical use in the USA, with smart laser.
Bruker Scientific LLC
8604784
Not in Commercial Distribution

  • 00841594100031 ()
8604784

  • Microbial identification mass spectrometry system IVD
Biotyper system for clinical use in the USA.
Bruker Scientific LLC
8603464
Not in Commercial Distribution

  • 00841594100024 ()
8603464

  • Microbial identification mass spectrometry system IVD
Central Axis Single 3pole for ceiling tube 70mm
S.I.M.E.O.N. Medical GmbH & Co. KG
111-0004490
In Commercial Distribution

  • 04250613814617 ()


  • Operating room light
No Description
Roche Diagnostics GmbH
09755594190
In Commercial Distribution

  • 07613336218334 ()
09755594190

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
09755586190
In Commercial Distribution

  • 07613336218327 ()
09755586190

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
No Description
Epocal Inc
HH-1009-CA-00
In Commercial Distribution

  • 00809708069117 ()
HH-1009-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R03-CA-00
In Commercial Distribution

  • 00809708064068 ()
HH-0R03-CA-00

  • Metabolic profile clinical chemistry analyser IVD
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