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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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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 AFP-L3 Calibrator Set - 04987481164437

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-60901
In Commercial Distribution

997-60901

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator

uTASWako DCP - 04987481164413

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-60701
In Commercial Distribution

995-60701

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

Autokit CH50 - 04987481164406

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-40801
In Commercial Distribution

995-40801

  • Total complement activity (CH50) IVD, reagent

uTASWako AFP-L3 - 04987481164390

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-60601
In Commercial Distribution

999-60601

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, reagent

VERSANT® Tissue Preparation Reagents (Box 3) - 00630414588810

VERSANT® Tissue Preparation Reagents (Box 3)
Siemens Healthcare Diagnostics Inc.
10632400
Not in Commercial Distribution

  • 00630414588810 ()
10632400

  • Nucleic acid extraction/isolation kit IVD

Lumipulse G B-Amyloid Controls (Plasma)-N - 04987270235485

Lumipulse G B-Amyloid Controls (Plasma)-N
FUJIREBIO INC.
235485
Not in Commercial Distribution

  • 04987270235485 ()

  • 4 bottles per unit; 1.0mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Lumipulse G B-Amyloid 1-42-N Plasma - 04987270235447

Lumipulse G B-Amyloid 1-42-N Plasma IRC
FUJIREBIO INC.
235447
In Commercial Distribution

  • 04987270235447 ()

  • 42 Tests per Kit


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Coating Material - 04560227798990

Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.
SUN MEDICAL CO.,LTD.
MC-002
Not in Commercial Distribution

  • 04560227798990 ()

  • Weight: 1.43 Kilogram
KS51US

  • Denture reliner, hard

SUPER-SNAP - 04548162235398

SUPER SNAP POLYSTRIPS, GN/RED
SHOFU DENTAL CORPORATION
L526
In Commercial Distribution

  • 04548162235398 ()
L526

  • Dental abrasive strip, single-use
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