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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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ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level.
STRECK, INC.
213330
In Commercial Distribution

  • 10844509000096 ()

  • Total Volume: 2.5 Milliliter
213330

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level.
STRECK, INC.
213325
In Commercial Distribution

  • 10844509000089 ()

  • Total Volume: 2.5 Milliliter
213325

  • Multiple CD cell marker IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61501
Not in Commercial Distribution

  • 10856626006189 ()
  • 00856626006182 ()
997-61501

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61001
Not in Commercial Distribution

  • 10856626006172 ()
  • 00856626006175 ()
997-61001

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
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
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61101
Not in Commercial Distribution

  • 10856626006073 ()
  • 00856626006076 ()
993-61101

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
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
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
990-28011
Not in Commercial Distribution

  • 10856626006035 ()
  • 00856626006038 ()
990-28011

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
464-01601
Not in Commercial Distribution

  • 10856626006028 ()
  • 00856626006021 ()
464-01601

  • Triglyceride IVD, calibrator
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