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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 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

Emit II Plus Oxycodone Assay 30 mL Kit - 00630414028019

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720808
In Commercial Distribution

  • 00630414028019 ()
9T039UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Emit II Plus Oxycodone Assay 115 mL Kit - 00630414027937

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720816
In Commercial Distribution

  • 00630414027937 ()
9T029UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Emit II Plus Oxycodone Assay 1 L Kit - 00630414027920

Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics Inc.
10720817
In Commercial Distribution

  • 00630414027920 ()
9T129UL

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

Altor Safety - 00850019086201

Altor Safety 4-Ply Surgical Mask (Model:62232) Inner Carton of 50 Masks
Altor Safety LLC
62232
In Commercial Distribution

62232

  • Surgical/medical face mask, non-antimicrobial, single-use
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