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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 L1-4, WBC L1-4, PLT L1-4.
STRECK, INC.
291709
In Commercial Distribution

  • 00844509001393 ()

  • Total Volume: 3.0 Milliliter
291709

  • Full blood count IVD, control
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 L1-4, PLT L1-4.
STRECK, INC.
291708
In Commercial Distribution

  • 00844509001386 ()

  • Total Volume: 3.0 Milliliter
291708

  • Full blood count IVD, control
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.
STRECK, INC.
291504
In Commercial Distribution

  • 00844509001379 ()

  • Total Volume: 3.0 Milliliter
291504

  • Full blood count IVD, control
A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 4 vials each of low, normal & high levels.
STRECK, INC.
225512
In Commercial Distribution

  • 00844509001188 ()

  • Total Volume: 4.0 Milliliter
225512

  • Full blood count IVD, control
A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 1 vial each of low, normal & high levels.
STRECK, INC.
225503
In Commercial Distribution

  • 00844509001171 ()

  • Total Volume: 4.0 Milliliter
225503

  • Full blood count IVD, control
Retic-Chex Linearity BC is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285535
In Commercial Distribution

  • 00844509001133 ()

  • Total Volume: 3.0 Milliliter
285535

  • Reticulocyte count IVD, control
Retic-Chex Linearity is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285633
In Commercial Distribution

  • 00844509001072 ()

  • Total Volume: 2.5 Milliliter
285633

  • Reticulocyte count IVD, control
Retic-Chex Linearity is designed to establish the patient reportable range and linearity of the system. Contains 1 vial each of levels 1-5.
STRECK, INC.
285532
In Commercial Distribution

  • 00844509001065 ()

  • Total Volume: 2.5 Milliliter
285532

  • Reticulocyte count IVD, control
A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter.
STRECK, INC.
285536
In Commercial Distribution

  • 00844509001003 ()

  • Total Volume: 2.0 Milliliter
285536

  • Glycated haemoglobin (HbA1c) IVD, control
A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.
STRECK, INC.
211130
In Commercial Distribution

  • 00844509000945 ()

  • Total Volume: 2.0 Milliliter
211130

  • Glycated haemoglobin (HbA1c) IVD, control
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