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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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COC300/OPI300/AMP1000/THC50/BZO300
BRANAN MEDICAL CORPORATION
QT15
Not in Commercial Distribution

  • 00816555020710 ()
QT15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ pBNP method.
Siemens Healthcare Diagnostics Inc.
10445087
In Commercial Distribution

  • 00842768019722 ()
  • 00630414009971 ()
CPBNPM-C

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care™ Troponin I Calibrator (cTNI CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ cTNI method.
Siemens Healthcare Diagnostics Inc.
10445072
In Commercial Distribution

  • 00842768004537 ()
  • 00630414009865 ()
CCTNI-CR

  • Troponin I IVD, kit, fluorescent immunoassay
Tacrolimus Calibrator, Levels 1-5, 2 bottles each
Siemens Healthcare Diagnostics Inc.
10700796
In Commercial Distribution

  • 00842768035432 ()
DC207

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Multi 1 Sample Diluent, 12x2mL
Siemens Healthcare Diagnostics Inc.
10469971
In Commercial Distribution

  • 00842768030314 ()
  • 00630414005690 ()
KD693

  • Buffered sample diluent IVD
Negative quality control for T2Biothreat Panel
T2 BIOSYSTEMS, INC.
85-11398
In Commercial Distribution

  • M70883113970 ()
  • M70885113983 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
T2 BIOSYSTEMS, INC.
85-11396
In Commercial Distribution

  • M70883113950 ()
  • M70885113963 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
Negative Control
T2 BIOSYSTEMS, INC.
85-08376
In Commercial Distribution

  • M70885083763 ()
  • M70885083760 ()
  • M70883083580 ()

  • Total Volume: 4 Milliliter


  • Multiple Candida species nucleic acid IVD, control
Negative Control
T2 BIOSYSTEMS, INC.
85-08376
Not in Commercial Distribution

  • M70885083760 ()

  • Total Volume: 4 Milliliter


  • Multiple Candida species nucleic acid IVD, control
Positive APG Control, Positive TPK Control
T2 BIOSYSTEMS, INC.
85-08375
In Commercial Distribution

  • M70885083750 ()

  • Total Volume: 4 Milliliter


  • Multiple Candida species nucleic acid IVD, control
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