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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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Validate GC1ab is intended for the quantitative determination of Calibration Verification/Linearity of general chemistries on automated instruments.
Lgc Clinical Diagnostics, Inc.
1100ab
In Commercial Distribution

  • 00859110005180 ()

  • 2 tests
1100ab

  • Multiple-type clinical chemistry analyte profile IVD, control
Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
In Commercial Distribution

  • 00860010518175 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-35191
In Commercial Distribution

  • 04987481164635 ()
  • 14987481164632 ()
993-35191

  • Non-esterified fatty acid IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-34891
In Commercial Distribution

  • 04987481164628 ()
  • 14987481164625 ()
991-34891

  • Non-esterified fatty acid IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-34791
In Commercial Distribution

  • 04987481164611 ()
  • 14987481164618 ()
995-34791

  • Non-esterified fatty acid IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-34691
In Commercial Distribution

  • 04987481164604 ()
  • 14987481164601 ()
999-34691

  • Non-esterified fatty acid IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-00504
In Commercial Distribution

  • 04987481164543 ()
  • 14987481164540 ()
999-00504

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-00404
In Commercial Distribution

  • 04987481164536 ()
  • 14987481164533 ()
999-00404

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-61401
In Commercial Distribution

  • 04987481164499 ()
  • 14987481164496 ()
  • 10856626006066 ()
991-61401

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-61301
In Commercial Distribution

  • 04987481164482 ()
  • 14987481164489 ()
  • 10856626006134 ()
995-61301

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