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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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No Description
Sonova AG
(beige)
In Commercial Distribution

  • 07613389718157 ()
050-1094-H067

  • Air-conduction hearing aid, receiver-in-canal
Verification of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose and lactate performance on the instrument.
Diamond Diagnostics Inc.
DD-92900
In Commercial Distribution

  • 00811403014798 ()


  • Multiple blood gas analyte IVD, control
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014326 ()
CDR-5

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014302 ()
CABC-5

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
Roche Diagnostics GmbH
08250499160
In Commercial Distribution

  • 07613336148280 ()
08250499160

  • Troponin T IVD, calibrator
No Description
Roche Diagnostics GmbH
08250472160
In Commercial Distribution

  • 07613336148273 ()
08250472160

  • Troponin T IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
08469890160
In Commercial Distribution

  • 07613336158982 ()
08469890160

  • Troponin T IVD, reagent
Troponin T G5 STAT Elecsys cobas e100 V2 (E1G)
Roche Diagnostics GmbH
08469865160
In Commercial Distribution

  • 07613336158951 ()
08469865160

  • Troponin T IVD, reagent
No Description
Ventana Medical Systems, Inc.
05251362001
In Commercial Distribution

  • 07613336125373 ()
05251362001

  • Assay container IVD, single-use
No Description
Ventana Medical Systems, Inc.
05271665001
In Commercial Distribution

  • 07613336125137 ()
05271665001

  • Assay container IVD, single-use
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