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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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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

NEFA Linearity Material - 04987481164642

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-76491
In Commercial Distribution

  • 04987481164642 ()
997-76491

  • Non-esterified fatty acid IVD, calibrator

Autokit Micro Albumin Calibrator Set - 04987481164529

In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-06101
In Commercial Distribution

995-06101

  • Microalbumin IVD, calibrator

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

OncoMate MSI Dx Analysis System - 00849811031717

Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
PROMEGA CORPORATION
MD2140
In Commercial Distribution

  • 00849811031717 ()
MD2140

  • Microsatellite instability IVD, kit, nucleic acid technique (NAT)

AccuTrak - 00850011135792

AccuTrak Abeta42 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0258
In Commercial Distribution

  • 00850011135792 ()


  • Amyloid B component IVD, control
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