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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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Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-100mL
In Commercial Distribution

  • 00893727002200 ()

  • Total Volume: 100 Milliliter
90128

  • IVF medium
CONT 550-10 CLOTTRAC RACT ABN 11L 15BX
MEDTRONIC, INC.
550-10
In Commercial Distribution

  • 10885074184927 ()
  • 00885074184920 ()


  • Multiple coagulation factor IVD, control
CONT 550-09 CLOTTRAC LR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-09
In Commercial Distribution

  • 10885074184910 ()
  • 00885074184913 ()


  • Multiple coagulation factor IVD, control
CONT 550-08 CLOTTRAC HR ABN BXD ASY 15BX
MEDTRONIC, INC.
550-08
In Commercial Distribution

  • 10885074184880 ()
  • 00885074184883 ()


  • Multiple coagulation factor IVD, control
CONTROL 550-07 CLOTTRAC HR 11L 15BX
MEDTRONIC, INC.
550-07
In Commercial Distribution

  • 10885074184873 ()
  • 00885074184876 ()


  • Multiple coagulation factor IVD, control
CONTROL 550-01 CLOTTRAC CWB 11L 15BX
MEDTRONIC, INC.
550-01
In Commercial Distribution

  • 10885074184828 ()
  • 00885074184821 ()


  • Multiple coagulation factor IVD, control
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
The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Beckman Coulter, Inc.
33211
In Commercial Distribution

  • H628332111 ()
33211

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay
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
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