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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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The Follistatin enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of follistatin in human serum and other biological fluids. This kit is intended for in-vitro diagnostic use.
Ansh Labs, LLC
AL-117-i
In Commercial Distribution

  • 00853592008387 ()
AL-117-i

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum. It is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
Ansh Labs, LLC
AL-123
In Commercial Distribution

  • 00853592008097 ()
AL-123

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum. It is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders. Down syndrome (Trisomy 21) screening in the 2nd trimester using combined biochemical and ultrasound markers may be assessed with appropriate risk calculation software.1,2 It is strongly recommended to use validated software (CE marked) designated specifically for evaluating the risk of Trisomy 21 using Inhibin A in combination with hAFP, hCG, and uE3 measurements.
Ansh Labs, LLC
AL-123-i
In Commercial Distribution

  • 00853592008073 ()
AL-123-i

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
The Activin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Activin A in human serum and other biological fluids. This assay is intended for in vitro diagnostic use.
Ansh Labs, LLC
AL-110-i
In Commercial Distribution

  • 00853592008059 ()
AL-110-i

  • Activin A IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
MA010
In Commercial Distribution

  • 05051700020329 ()


  • Total immunoglobulin A (IgA total) IVD, reagent
No Description
THE BINDING SITE GROUP LIMITED
NQ624.OPT
In Commercial Distribution

  • 05051700019439 ()


  • Total immunoglobulin A (IgA total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ623.OPT
In Commercial Distribution

  • 05051700019422 ()


  • Total immunoglobulin A (IgA total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ087.OPT
In Commercial Distribution

  • 05051700019330 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ088.OPT
In Commercial Distribution

  • 05051700019262 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ010.OPT
In Commercial Distribution

  • 05051700019101 ()


  • Total immunoglobulin A (IgA total) IVD, control
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