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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 - 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

Aution™ AU Control Solution - 04987486738060

Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
73806
In Commercial Distribution

  • 04987486738060 ()


  • Multiple urine analyte IVD, control

Autokit Micro Albumin Control Set - 04987481164673

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-06201
In Commercial Distribution

  • 04987481164673 ()
991-06201

  • Albumin IVD, control

Autokit Micro Albumin - 04987481164666

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-06001
In Commercial Distribution

  • 04987481164666 ()
999-06001

  • Albumin IVD, kit, nephelometry/turbidimetry

Complement Control - 04987481164659

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-43701
In Commercial Distribution

  • 04987481164659 ()
991-43701

  • Total complement activity (CH50) IVD, control

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

Liquichek - 00847661004301

Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292X
In Commercial Distribution

  • 00847661004301 ()
292X

  • Glycated haemoglobin (HbA1c) IVD, control

Liquichek - 00847661004295

Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
293
In Commercial Distribution

  • 00847661004295 ()
293

  • Glycated haemoglobin (HbA1c) IVD, control
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