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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
Ventana Medical Systems, Inc.
05271665001
In Commercial Distribution

  • 07613336125137 ()
05271665001

  • Assay container IVD, single-use
No Description
Ventana Medical Systems, Inc.
05271886001
In Commercial Distribution

  • 07613336125045 ()
05271886001

  • Assay container IVD, single-use
No Description
Ventana Medical Systems, Inc.
05271550001
In Commercial Distribution

  • 07613336124956 ()
05271550001

  • Assay container IVD, single-use
No Description
Ventana Medical Systems, Inc.
05271762001
In Commercial Distribution

  • 07613336124840 ()
05271762001

  • Assay container IVD, single-use
The Ammonia Standards are intended for the calibration of ammonia assays.
POINTE SCIENTIFIC, INC.
A7553-STD500
In Commercial Distribution

  • 00811727010278 ()
A7553-STD500

  • Ammonia IVD, calibrator
No Description
Neotech Products LLC
00812594012396
In Commercial Distribution

  • 00812594012396 ()
N9105CO-B

  • Tracheostomy tube neck holder, reusable
No Description
Neotech Products LLC
00812594012327
In Commercial Distribution

  • 00812594012327 ()
N9105BL-B

  • Tracheostomy tube neck holder, reusable
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
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
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