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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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Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-5, PLT L1-5.
STRECK, INC.
291710
In Commercial Distribution

  • 00844509001409 ()

  • Total Volume: 3.0 Milliliter
291710

  • Full blood count IVD, control
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 2 vials each of level 1, 2 & 3.
STRECK, INC.
285106
In Commercial Distribution

  • 00844509000433 ()

  • Total Volume: 1.0 Milliliter
285106

  • Reticulocyte count IVD, control
A tri-level control manufactured with reticulocytes that resemble the appearance of patient samples for accurate identification. Contains 1 vial each of level 1, 2 & 3 and 1 vial of stain.
STRECK, INC.
285101
In Commercial Distribution

  • 00844509000426 ()

  • Total Volume: 1.0 Milliliter
285101

  • Reticulocyte count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 1 vial each of low, normal & high levels.
STRECK, INC.
225489
In Commercial Distribution

  • 00844509000365 ()

  • Total Volume: 4.5 Milliliter
225489

  • Full blood count IVD, control
A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials each of low, normal & high levels.
STRECK, INC.
225485
In Commercial Distribution

  • 00844509000358 ()

  • Total Volume: 4.5 Milliliter
225485

  • Full blood count IVD, control
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 1 vial each of L1-UC, L1-CC, LV2.
STRECK, INC.
212431
In Commercial Distribution

  • 00844509000303 ()

  • Total Volume: 2.0 Milliliter
212431

  • Full blood count IVD, control
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials each of L1-UC and L2.
STRECK, INC.
212425
In Commercial Distribution

  • 00844509000297 ()

  • Total Volume: 2.0 Milliliter
212425

  • Full blood count IVD, control
Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 2 vials each of L1-UC and L2.
STRECK, INC.
212420
In Commercial Distribution

  • 00844509000280 ()

  • Total Volume: 2.0 Milliliter
212420

  • Full blood count IVD, control
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 4 vials each of low, normal and high levels.
STRECK, INC.
218913
In Commercial Distribution

  • 00844509000235 ()

  • Total Volume: 3.0 Milliliter
218913

  • Full blood count IVD, control
A whole blood hematology control specifically formulated for the Abbott CELL-DYN® 5-part differential instruments. Contains 2 vials each of low, normal and high levels.
STRECK, INC.
218907
In Commercial Distribution

  • 00844509000228 ()

  • Total Volume: 3.0 Milliliter
218907

  • Full blood count IVD, control
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