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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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Potassium electrode - 07613336227770

No Description
Roche Diagnostics GmbH
10825441001
In Commercial Distribution

  • 07613336227770 ()
10825441001

  • Potassium (K+) IVD, kit, ion-selective electrode (ISE)

uTASWako DCP Control L - 10856626006134

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-61301
Not in Commercial Distribution

  • 10856626006134 ()
  • 00856626006137 ()
995-61301

  • Des-gamma-carboxyprothrombin (DCP) IVD, control

uTASWako DCP Control H - 10856626006066

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-61401
Not in Commercial Distribution

  • 10856626006066 ()
  • 00856626006069 ()
991-61401

  • Des-gamma-carboxyprothrombin (DCP) IVD, control

uTASWako DCP Control H - 14987481164496

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-61401
In Commercial Distribution

  • 04987481164499 ()
  • 14987481164496 ()
  • 10856626006066 ()
991-61401

  • Des-gamma-carboxyprothrombin (DCP) IVD, control

uTASWako DCP Control L - 14987481164489

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-61301
In Commercial Distribution

  • 04987481164482 ()
  • 14987481164489 ()
  • 10856626006134 ()
995-61301

  • Des-gamma-carboxyprothrombin (DCP) IVD, control

ON-Q* Pain Relief System with SELECT-A-FLOW - 00193494000141

No Description
Avanos Medical, Inc.
PSAF02-N
In Commercial Distribution

  • 10193494000148 ()
  • 00193494000141 ()
PSAF02-N

  • Des-gamma-carboxyprothrombin (DCP) IVD, control

uTASWako DCP Calibrator Set - 04987481164475

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-61201
In Commercial Distribution

999-61201

  • Des-gamma-carboxyprothrombin (DCP) IVD, calibrator

uTASWako DCP Calibrator Set - 00856626006212

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-61201
Not in Commercial Distribution

  • 00856626006212 ()
999-61201

  • Des-gamma-carboxyprothrombin (DCP) IVD, calibrator

ON-Q* Pain Relief System with ONDEMAND* Bolus Button, NRFit™ Connector - 00193494000066

No Description
Avanos Medical, Inc.
PMB01-N
In Commercial Distribution

  • 10193494000063 ()
  • 00193494000066 ()
PMB01-N

  • Des-gamma-carboxyprothrombin (DCP) IVD, calibrator

Diazyme - 00817089021228

No Description
DIAZYME LABORATORIES, INC.
DZ113C-K01
In Commercial Distribution

  • 00817089021228 ()


  • Potassium (K+) IVD, reagent
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