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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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Alinity - 00380740136895

Alinity s Optics Verifier Kit
Abbott Ireland Diagnostics
01R3565
In Commercial Distribution

  • 00380740136895 ()
01R3565

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use

CELL-DYN - 00380740119843

CELL-DYN 22 Plus Calibrator
ABBOTT LABORATORIES
09H73-01
In Commercial Distribution

  • 00380740119843 ()
09H7301

  • Full blood count IVD, calibrator

CELL-DYN - 00380740119836

CELL-DYN 22 Plus Control
ABBOTT LABORATORIES
09H72-02
In Commercial Distribution

  • 00380740119836 ()
09H7202

  • Full blood count IVD, control

CELL-DYN - 00380740119829

CELL-DYN 22 Plus Control
ABBOTT LABORATORIES
09H72-01
In Commercial Distribution

  • 00380740119829 ()
09H7201

  • Full blood count IVD, control

CELL-DYN - 00380740020347

CELL-DYN 18 PLUS CALIBRATOR
ABBOTT LABORATORIES
09H70-01
In Commercial Distribution

  • 00380740020347 ()
09H7001

  • Full blood count IVD, calibrator

CELL-DYN - 00380740020330

CELL-DYN 18 PLUS CONTROL
ABBOTT LABORATORIES
09H69-02
In Commercial Distribution

  • 00380740020330 ()
09H6902

  • Full blood count IVD, control

CELL-DYN - 00380740020323

CELL-DYN 18 PLUS CONTROL
ABBOTT LABORATORIES
09H69-01
In Commercial Distribution

  • 00380740020323 ()
09H6901

  • Full blood count IVD, control

ESR-Chex Plus - 00844509002192

A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 2 vials each of level 1 & 2.
STRECK, INC.
240411
In Commercial Distribution

  • 00844509002192 ()

  • Total Volume: 3.0 Milliliter
240411

  • Erythrocyte sedimentation rate (ESR) IVD, control

ESR-Chex Plus - 00844509002185

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

UA-Cellular for UF - 00844509001997

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
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