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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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In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61101
In Commercial Distribution

  • 04987481164451 ()
  • 14987481164458 ()
  • 10856626006073 ()
993-61101

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61001
In Commercial Distribution

  • 04987481164444 ()
  • 14987481164441 ()
  • 10856626006172 ()
997-61001

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
464-01601
In Commercial Distribution

  • 04987481102927 ()
  • 14987481102924 ()
  • 10856626006028 ()
464-01601

  • Triglyceride IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
276-76491
In Commercial Distribution

  • 04987481100992 ()
  • 14987481100999 ()
  • 10856626006011 ()
276-76491

  • Non-esterified fatty acid IVD, calibrator
No Description
IMMUCOR GTI DIAGNOSTICS, INC.
628075
In Commercial Distribution

  • 10888234400134 ()
628075

  • DNA amplification enzyme reagent IVD
Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test.
IMMUCOR, INC.
0066428
In Commercial Distribution

  • 10888234002437 ()
0066428

  • Anti-S [MNS003] red blood cell grouping IVD, antibody
Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen on red blood cells by tube test.
IMMUCOR, INC.
0066429
In Commercial Distribution

  • 10888234002420 ()
0066429

  • Anti-S [MNS004] red blood cell grouping IVD, antibody
Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent is intended for the detection of the k (KEL2) antigen on red blood cells by indirect agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004817
In Commercial Distribution

  • 10888234002390 ()
0004817

  • Anti-k (KEL002) red blood cell grouping IVD, antibody
Anti-Fyb (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Fyb (FY2) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004818
In Commercial Distribution

  • 10888234002383 ()
0004818

  • Anti-Fy^b red blood cell grouping IVD, antibody
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