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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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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
A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2.
STRECK, INC.
211124
In Commercial Distribution

  • 00844509000938 ()

  • Total Volume: 2.0 Milliliter
211124

  • Glycated haemoglobin (HbA1c) IVD, control
A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 2 each of P+ & N-
STRECK, INC.
217654
In Commercial Distribution

  • 00844509000891 ()

  • Total Volume: 2.5 Milliliter
217654

  • Haemoglobin S (HbS) IVD, control
A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 1 each of P+ & N-
STRECK, INC.
217653
In Commercial Distribution

  • 00844509000884 ()

  • Total Volume: 2.5 Milliliter
217653

  • Haemoglobin S (HbS) IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 4 vials each of normal & high levels.
STRECK, INC.
215428
In Commercial Distribution

  • 00844509000815 ()

  • Total Volume: 1.5 Milliliter
215428

  • 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 each of low, normal & high levels.
STRECK, INC.
215418
In Commercial Distribution

  • 00844509000808 ()

  • Total Volume: 1.5 Milliliter
215418

  • 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 4 vials each of low, normal & high levels.
STRECK, INC.
215412
In Commercial Distribution

  • 00844509000792 ()

  • Total Volume: 1.5 Milliliter
215412

  • Full blood count IVD, control
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