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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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100SH 10X12IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
In Commercial Distribution

  • 60889971043214 ()
  • 40889971043210 ()
  • 00889971043212 ()
1043215

  • Medical x-ray film, non-screen
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of normal level.
STRECK, INC.
215416
In Commercial Distribution

  • 40844509000691 ()

  • Total Volume: 1.5 Milliliter
215416

  • Full blood count IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of low level.
STRECK, INC.
215426
In Commercial Distribution

  • 40844509000684 ()

  • Total Volume: 1.5 Milliliter
215426

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of high level.
STRECK, INC.
218753
In Commercial Distribution

  • 40844509000639 ()

  • Total Volume: 2.5 Milliliter
218753

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of low level.
STRECK, INC.
218751
In Commercial Distribution

  • 40844509000622 ()

  • Total Volume: 2.5 Milliliter
218751

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of normal level.
STRECK, INC.
218995
In Commercial Distribution

  • 40844509000615 ()

  • Total Volume: 4.5 Milliliter
218995

  • Full blood count IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
STRECK, INC.
213377
In Commercial Distribution

  • 40844509000523 ()

  • Total Volume: 3.0 Milliliter
213377

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of Normal level.
STRECK, INC.
213378
In Commercial Distribution

  • 40844509000516 ()

  • Total Volume: 3.0 Milliliter
213378

  • Multiple CD cell marker IVD, control
A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
STRECK, INC.
221108
In Commercial Distribution

  • 40844509000318 ()

  • Total Volume: 3.0 Milliliter
221108

  • Full blood count IVD, calibrator
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level CD4L
STRECK, INC.
213324
In Commercial Distribution

  • 40844509000141 ()

  • Total Volume: 3.0 Milliliter
213324

  • Multiple CD cell marker IVD, control
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