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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 two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 6 vials each of level 1 & 2.
STRECK, INC.
240408
In Commercial Distribution

  • 00844509002185 ()

  • Total Volume: 3.0 Milliliter
240408

  • Erythrocyte sedimentation rate (ESR) IVD, control
Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213465
In Commercial Distribution

  • 00844509001997 ()

  • Total Volume: 45 Milliliter
213465

  • Urine sediment IVD, control
Urinalysis control designed specifically for the Iris Diagnostics iQ® automated urine analyzers. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213396
In Commercial Distribution

  • 00844509001966 ()

  • Total Volume: 120 Milliliter
213396

  • Urine sediment IVD, control
A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains 1 vial each of L-PC,PCM & NC.
STRECK, INC.
218991
In Commercial Distribution

  • 00844509001935 ()

  • Total Volume: 120 Milliliter
218991

  • Urine sediment IVD, control
A positive/negative post-vasectomy sperm count control. Contains 1 vial each of positive & negative control.
STRECK, INC.
230200
In Commercial Distribution

  • 00844509001898 ()

  • Total Volume: 300 Microliter
230200

  • Sperm concentration indicator IVD, control
A sperm count control containing stabilized sperm. Contains 1 vial each of level 1 & 2.
STRECK, INC.
230202
In Commercial Distribution

  • 00844509001867 ()

  • Total Volume: 300 Microliter
230202

  • Sperm concentration indicator IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 1 vial each of level 2 & 3.
STRECK, INC.
232758
In Commercial Distribution

  • 00844509001737 ()

  • Total Volume: 2.5 Milliliter
232758

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 3 vials each of level 1 & 3.
STRECK, INC.
232757
In Commercial Distribution

  • 00844509001720 ()

  • Total Volume: 2.5 Milliliter
232757

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 2 vials each of level 1, 2 & 3.
STRECK, INC.
232756
In Commercial Distribution

  • 00844509001713 ()

  • Total Volume: 2.5 Milliliter
232756

  • Glucose/haemoglobin (Hb) IVD, control
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 1 vial each of level 1, 2 & 3.
STRECK, INC.
232749
In Commercial Distribution

  • 00844509001706 ()

  • Total Volume: 2.5 Milliliter
232749

  • Glucose/haemoglobin (Hb) IVD, control
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