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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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For the quantitative determination of direct bilirubin in human serum. For in vitro diagnostic use.
IDG/SANZAY Corporation
1
In Commercial Distribution

  • 00850053916045 ()

  • Total Volume: 100 Milliliter
  • Total Volume: 240 Milliliter
  • Total Volume: 1 Liter
  • Total Volume: 250 Milliliter
  • Total Volume: 480 Milliliter
C071

  • Conjugated (direct) bilirubin IVD, reagent
Multi-Link™ ECG Leadwire, 6-lead, Grabber, IEC, 74 cm/29 in & 130 cm/51 in
AirLife Finland Oy
421933-003
In Commercial Distribution

421933-003

  • Electrocardiographic lead set, reusable
Multi-Link™ ECG Leadwire, 6-lead, Grabber, AHA, 74 cm/29 in & 130 cm/51 in
AirLife Finland Oy
421932-003
In Commercial Distribution

421932-003

  • Electrocardiographic lead set, reusable
Multi-Link™ ECG Leadwire, 6-lead, Snap, AHA, 74 cm/29 in & 130 cm/51 in
AirLife Finland Oy
421930-003
In Commercial Distribution

421930-003

  • Electrocardiographic lead set, reusable
Intended for use in the quality control of coagulation assays in the borderline pathological range.
Affinity Biologicals Inc
FRABP0125
In Commercial Distribution

  • 10629009061255 ()
  • 10629009060012 ()
  • 16290090061253 ()


  • Multiple coagulation factor IVD, control
Intended for use in the quality control of coagulation assays in the borderline pathological range.
Affinity Biologicals Inc
FRABP0105
In Commercial Distribution

  • 10629009061057 ()
  • 10629009060012 ()
  • 16290090061055 ()


  • Multiple coagulation factor IVD, control
For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
120mL
In Commercial Distribution

  • 00812137011947 ()
501-407

  • Carbon dioxide (CO2) IVD, reagent
For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
C7502-1L
In Commercial Distribution

  • 00811727010681 ()
C7502-1L

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
C7502-480
In Commercial Distribution

  • 00811727010674 ()
C7502-480

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
C7502-120
In Commercial Distribution

  • 00811727010667 ()
C7502-120

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
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