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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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ESR-Chex - 00844509001638

A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 2 vials each of level 1 & 2.
STRECK, INC.
214104
In Commercial Distribution

  • 00844509001638 ()

  • Total Volume: 9.0 Milliliter
214104

  • Erythrocyte sedimentation rate (ESR) IVD, control

ESR-Chex - 00844509001621

A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 1 vial each of level 1 & 2.
STRECK, INC.
214102
In Commercial Distribution

  • 00844509001621 ()

  • Total Volume: 9.0 Milliliter
214102

  • Erythrocyte sedimentation rate (ESR) IVD, control

CVA for CellDyn - 00844509001591

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

CVA for CellDyn - 00844509001584

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

CVA for CellDyn - 00844509001577

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

CVA for CellDyn - 00844509001560

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

CVA - 00844509001447

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.
291714
In Commercial Distribution

  • 00844509001447 ()

  • Total Volume: 3.0 Milliliter
291714

  • Full blood count IVD, control

CVA - 00844509001430

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 L1-7.
STRECK, INC.
291713
In Commercial Distribution

  • 00844509001430 ()

  • Total Volume: 3.0 Milliliter
291713

  • Full blood count IVD, control

CVA - 00844509001423

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 L1-7, PLT L1-6
STRECK, INC.
291712
In Commercial Distribution

  • 00844509001423 ()

  • Total Volume: 3.0 Milliliter
291712

  • Full blood count IVD, control

CVA - 00844509001416

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 L1-5.
STRECK, INC.
291711
In Commercial Distribution

  • 00844509001416 ()

  • Total Volume: 3.0 Milliliter
291711

  • Full blood count IVD, control
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