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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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Lumipulse G Testosterone Immunoreaction Cartridges - 04987270235393

No Description
FUJIREBIO INC.
235393
In Commercial Distribution

  • 04987270235393 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Total testosterone IVD, kit, chemiluminescent immunoassay

Lumipulse G LH Immunoreaction Cartridges - 04987270235270

No Description
FUJIREBIO INC.
235270
Not in Commercial Distribution

  • 04987270235270 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Lumipulse G Progesterone-N Immunoreaction Cartridges - 04987270235256

No Description
FUJIREBIO INC.
235256
Not in Commercial Distribution

  • 04987270235256 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Progesterone IVD, kit, chemiluminescent immunoassay

Lumipulse G FSH-N Immunoreaction Cartridges - 04987270235218

No Description
FUJIREBIO INC.
235218
Not in Commercial Distribution

  • 04987270235218 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Lumipulse G Prolactin Immunoreaction Cartridges - 04987270235195

No Description
FUJIREBIO INC.
235195
Not in Commercial Distribution

  • 04987270235195 ()

  • Size Type = Tests per Kit; Size Unit = 42; Unit of Measure = Tests


  • Prolactin IVD, kit, chemiluminescent immunoassay

Lumipulse G E2-III Immunoreaction Cartridges - 04987270235171

No Description
FUJIREBIO INC.
235171
In Commercial Distribution

  • 04987270235171 ()

  • Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Lumipulse G Specimen Diluent 6 - 04987270234693

No Description
FUJIREBIO INC.
234693
In Commercial Distribution

  • 04987270234693 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD

Lumipulse G Specimen Diluent 1 - 04987270231203

No Description
FUJIREBIO INC.
231203
In Commercial Distribution

  • 04987270231203 ()

  • Total Volume: 1200 Milliliter


  • Buffered sample diluent IVD

Lumipulse G Substrate Solution - 04987270231197

No Description
FUJIREBIO INC.
231197
In Commercial Distribution

  • 04987270231197 ()

  • Total Volume: 600 Milliliter


  • Chemiluminescent substrate reagent IVD

Lumipulse G Wash Solution - 04987270231173

No Description
FUJIREBIO INC.
231173
In Commercial Distribution

  • 04987270231173 ()

  • Total Volume: 1000 Milliliter


  • Buffered wash solution IVD
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