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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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A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 2.
STRECK, INC.
232754
In Commercial Distribution

  • 20844509001687 ()

  • Total Volume: 2.5 Milliliter
232754

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 1.
STRECK, INC.
232753
In Commercial Distribution

  • 20844509001670 ()

  • Total Volume: 2.5 Milliliter
232753

  • Glucose/haemoglobin (Hb) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials of level 2.
STRECK, INC.
214024
In Commercial Distribution

  • 20844509001618 ()

  • Total Volume: 9.0 Milliliter
214024

  • Erythrocyte sedimentation rate (ESR) IVD, control
A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials of level 1.
STRECK, INC.
214014
In Commercial Distribution

  • 20844509001601 ()

  • Total Volume: 9.0 Milliliter
214014

  • Erythrocyte sedimentation rate (ESR) 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 of high level.
STRECK, INC.
225534
In Commercial Distribution

  • 20844509001168 ()

  • Total Volume: 4.0 Milliliter
225534

  • 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 12 vials of normal level.
STRECK, INC.
225114
In Commercial Distribution

  • 20844509001151 ()

  • Total Volume: 4.0 Milliliter
225114

  • 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 of low level.
STRECK, INC.
225524
In Commercial Distribution

  • 20844509001144 ()

  • Total Volume: 4.0 Milliliter
225524

  • Full blood count IVD, control
Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 3.
STRECK, INC.
200069
In Commercial Distribution

  • 20844509000574 ()

  • Total Volume: 3.0 Milliliter
200069

  • Full blood count IVD, control
Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 2.
STRECK, INC.
200068
In Commercial Distribution

  • 20844509000567 ()

  • Total Volume: 3.0 Milliliter
200068

  • Full blood count IVD, control
Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 1.
STRECK, INC.
200067
In Commercial Distribution

  • 20844509000550 ()

  • Total Volume: 3.0 Milliliter
200067

  • Full blood count IVD, control
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