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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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BAG,BANDED,CIRCULAR,STERILE,20"
MEDLINE INDUSTRIES, INC.
DYNJE60020S
In Commercial Distribution

  • 10080196073320 ()
DYNJE60020S

  • Sterilization packaging, single-use
BD BBL™ GasPak™ 100 Anaerobic System, Vented
BECTON, DICKINSON AND COMPANY
260627
Not in Commercial Distribution

  • 00382902606277 ()
260627

  • Atmospheric generation kit IVD
BD BBL™ GasPak™ 100 Anaerobic System
BECTON, DICKINSON AND COMPANY
260626
Not in Commercial Distribution

  • 00382902606260 ()
260626

  • Atmospheric generation kit IVD
No Description
FUJIREBIO INC.
231203
In Commercial Distribution

  • 04987270231203 ()

  • Total Volume: 1200 Milliliter


  • Buffered sample diluent IVD
No Description
FUJIREBIO INC.
231197
In Commercial Distribution

  • 04987270231197 ()

  • Total Volume: 600 Milliliter


  • Chemiluminescent substrate reagent IVD
No Description
FUJIREBIO INC.
231173
In Commercial Distribution

  • 04987270231173 ()

  • Total Volume: 1000 Milliliter


  • Buffered wash solution IVD
No Description
FUJIREBIO INC.
231135
Not in Commercial Distribution

  • 04987270231135 ()

  • Size Type = Units per Kit; Units = 3; Unit of Meaure = 4.5mLs


  • Thyroid stimulating hormone (TSH) IVD, calibrator
No Description
FUJIREBIO INC.
231111
In Commercial Distribution

  • 04987270231111 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator
No Description
FUJIREBIO INC.
230985
In Commercial Distribution

  • 04987270230985 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD
No Description
FUJIREBIO INC.
230954
Not in Commercial Distribution

  • 04987270230954 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Prolactin IVD, calibrator
No Description
FUJIREBIO INC.
230930
Not in Commercial Distribution

  • 04987270230930 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure 3.0mLs


  • Follicle stimulating hormone (FSH) IVD, calibrator
No Description
FUJIREBIO INC.
230916
Not in Commercial Distribution

  • 04987270230916 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Luteinizing hormone (LH) IVD, calibrator
No Description
FUJIREBIO INC.
230893
Not in Commercial Distribution

  • 04987270230893 ()

  • Size Type = Units per Kit; Units = 3; Unit of Measure = 4.5mLs


  • Progesterone IVD, calibrator
No Description
FUJIREBIO INC.
230879
In Commercial Distribution

  • 04987270230879 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD
No Description
FUJIREBIO INC.
230862
In Commercial Distribution

  • 04987270230862 ()

  • Size Type = Units per kit; Units = 6; Unit of Measure = 9.0mLs


  • Total testosterone IVD, calibrator
No Description
FUJIREBIO INC.
230688
In Commercial Distribution

  • 04987270230688 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs


  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
FUJIREBIO INC.
230664
Not in Commercial Distribution

  • 04987270230664 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
No Description
FUJIREBIO INC.
230640
In Commercial Distribution

  • 04987270230640 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
No Description
FUJIREBIO INC.
230213
Not in Commercial Distribution

  • 04987270230213 ()

  • Size Type = Units per Kit; Units = 4; Unit of Measure = 12mLs


  • Parathyroid hormone (PTH) IVD, control
No Description
FUJIREBIO INC.
230206
Not in Commercial Distribution

  • 04987270230206 ()

  • Size Type =Units per Kit; Units = 2; Unit of Measure = 4.5mLs


  • Parathyroid hormone (PTH) IVD, calibrator
No Description
FUJIREBIO INC.
230190
Not in Commercial Distribution

  • 04987270230190 ()

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


  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
260340
In Commercial Distribution

  • 04987270260340 ()

  • Number of tests per kit: 42


  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay
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
No Description
FUJIREBIO INC.
235294
Not in Commercial Distribution

  • 04987270235294 ()

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


  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
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
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
No Description
FUJIREBIO INC.
235232
In Commercial Distribution

  • 04987270235232 ()

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


  • Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay
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
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
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
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