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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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Uric Acid Reagent - 00812137012050

For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout. Increased uric acid levels are also found in leukemia, polycythemia, familial idiopathic hyperuricemia, and conditions associated with decreased renal function.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
500mL
In Commercial Distribution

  • 00812137012050 ()
501-418

  • Uric acid IVD, reagent

DEFIB Pads - 00813150020008

Cardiac Science Adult AED Pad
GRAPHIC CONTROLS ACQUISITION CORP
D326
Not in Commercial Distribution

  • 00813150020008 ()
  • 10813150020005 ()
D326

  • Electrode conductive skin pad, single-use

Elecsys AMH - 07613336166284

No Description
Roche Diagnostics GmbH
08819319160
In Commercial Distribution

  • 07613336166284 ()
08819319160

  • Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)

Audit MicroControls Linearity FD Traumatic Brain Injury (TBI) - B085K739M100

No Description
AALTO SCIENTIFIC
K739M-10
In Commercial Distribution

  • B085K739M100 ()


  • Multiple traumatic brain injury marker IVD, control

Audit MicroControls Linearity FD BNP (Extended) - B085K737M50

No Description
AALTO SCIENTIFIC
K737M-5
In Commercial Distribution

  • B085K737M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Audit MicroControls Linearity FD BNP (High) - B085K713M50

No Description
AALTO SCIENTIFIC
K713M-5
In Commercial Distribution

  • B085K713M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Audit MicroControls Linearity FD BNP (Low) - B085K708M50

No Description
AALTO SCIENTIFIC
K708M-5
In Commercial Distribution

  • B085K708M50 ()


  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Uric Acid ver.2 - 07613336121580

No Description
Roche Diagnostics GmbH
08058750190
In Commercial Distribution

  • 07613336121580 ()
08058750190

  • Uric acid IVD, kit, spectrophotometry

LIFEPAK CR2 - 07613327681857

USED LPCR2,WIFI,B,EN-US,ES-ES,S,2,ROS,MODET,ROS
PHYSIO-CONTROL, INC.
99512
In Commercial Distribution

  • 07613327681857 ()
99512-001265U

  • Non-rechargeable public semi-automated external defibrillator

LIFEPAK 15 MONITOR/DEFIBRILLATOR - 07613327666663

USED LP15,EN,SPO2,3L,EX,CO2,TR,VR,MNC,V4
PHYSIO-CONTROL, INC.
99577
In Commercial Distribution

  • 07613327666663 ()
99577-002178U

  • Physiologic-monitoring defibrillation system
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