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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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CELL-DYN HemCal Plus Calibrator
ABBOTT LABORATORIES
08H57-01
In Commercial Distribution

  • 00380740017071 ()
08H5701

  • Full blood count IVD, calibrator
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 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
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.
291722
In Commercial Distribution

  • 00844509001669 ()

  • Total Volume: 3.0 Milliliter
291722

  • 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 PLT L1-6.
STRECK, INC.
291720
In Commercial Distribution

  • 00844509001591 ()

  • Total Volume: 3.0 Milliliter
291720

  • 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 WBC L1-5.
STRECK, INC.
291719
In Commercial Distribution

  • 00844509001584 ()

  • Total Volume: 3.0 Milliliter
291719

  • 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 L1-5, PLT L1-6.
STRECK, INC.
291718
In Commercial Distribution

  • 00844509001577 ()

  • Total Volume: 3.0 Milliliter
291718

  • 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 L1-4, WBC L1-4, PLT L1-4.
STRECK, INC.
291715
In Commercial Distribution

  • 00844509001560 ()

  • Total Volume: 3.0 Milliliter
291715

  • Full blood count IVD, control
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