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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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BD BBL™ GasPak™ 100 Anaerobic System, Vented - 00382902606277

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 - 00382902606260

BD BBL™ GasPak™ 100 Anaerobic System
BECTON, DICKINSON AND COMPANY
260626
Not in Commercial Distribution

  • 00382902606260 ()
260626

  • Atmospheric generation kit 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

Lumipulse G TSH-III Calibrators - 04987270231135

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

Lumipulse G BHCG Calibrators - 04987270231111

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

Lumipulse G Specimen Diluent 2 - 04987270230985

No Description
FUJIREBIO INC.
230985
In Commercial Distribution

  • 04987270230985 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD

Lumipulse G Prolactin Calibrators - 04987270230954

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

Lumipulse G FSH-N Calibrators - 04987270230930

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

Lumipulse G LH Calibrators - 04987270230916

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

Lumipulse G Progesterone-N Calibrators - 04987270230893

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

Lumipulse G Specimen Diluent 3 - 04987270230879

No Description
FUJIREBIO INC.
230879
In Commercial Distribution

  • 04987270230879 ()

  • Total Volume: 20 Milliliter


  • Buffered sample diluent IVD

Lumipulse G Testosterone Calibrators - 04987270230862

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

Lumipulse G CA125II Calibrators - 04987270230688

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

Lumipulse G CA 19-9-N Calibrators - 04987270230664

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

Lumipulse G CA 15-3 Calibrators - 04987270230640

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

Lumipulse PTH Controls - 04987270230213

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

Lumipulse G Whole PTH Calibrators - 04987270230206

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

Lumipulse G whole PTH Immunoreaction Cartridges - 04987270230190

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

Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges - 04987270260340

No Description
FUJIREBIO INC.
260340
In Commercial Distribution

  • 04987270260340 ()

  • Number of tests per kit: 42


  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay

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 TSH-III Immunoreaction Cartridges - 04987270235294

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

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 BHCG Immunoreaction Cartridges - 04987270235232

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

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 Mesothelin Immunoreaction Cartridges - 04987270235157

No Description
FUJIREBIO INC.
235157
In Commercial Distribution

  • 04987270235157 ()

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


  • Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay

Lumipulse G CA 19-9-N Immunoreaction Cartridges - 04987270235126

No Description
FUJIREBIO INC.
235126
Not in Commercial Distribution

  • 04987270235126 ()

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


  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Lumipulse G CA 15-3 Immunoreaction Cartridges - 04987270235102

No Description
FUJIREBIO INC.
235102
In Commercial Distribution

  • 04987270235102 ()

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


  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges - 04987270235089

No Description
FUJIREBIO INC.
235089
Not in Commercial Distribution

  • 04987270235089 ()

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


  • Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

Lumipulse G BRAHMS PCT Immunoreaction Cartridges - 04987270235058

No Description
FUJIREBIO INC.
235058
In Commercial Distribution

  • 04987270235058 ()

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


  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Lumipulse G TP-N Immunoreaction Cartridges Set - 04987270235041

No Description
FUJIREBIO INC.
235041
In Commercial Distribution

  • 04987270235041 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 2mL
  • Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Lumipulse BRAHMS PCT Controls - 04987270234945

No Description
FUJIREBIO INC.
234945
In Commercial Distribution

  • 04987270234945 ()

  • Size Type =Units per Kit; Units = 14; Unit of Measure = 20mLs


  • Procalcitonin (PCT) IVD, control

Lumipulse G BRAHMS PCT Calibrator Set - 04987270234938

No Description
FUJIREBIO INC.
234938
In Commercial Distribution

  • 04987270234938 ()

  • Size Type = Units per Kit; Units = 5; Unit of Measure = 10mLs


  • Procalcitonin (PCT) IVD, calibrator

Lumipulse B-Amyloid Controls - 04987270234907

No Description
FUJIREBIO INC.
234907
In Commercial Distribution

  • 04987270234907 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, control

Lumipulse G B-Amyloid 1-40 Calibrator Set - 04987270234891

No Description
FUJIREBIO INC.
234891
In Commercial Distribution

  • 04987270234891 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator

Lumipulse G B-Amyloid 1-42 Calibrator Set - 04987270234884

No Description
FUJIREBIO INC.
234884
In Commercial Distribution

  • 04987270234884 ()

  • Number of Bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator
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