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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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Checkcell - 10888234000181

Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002224
In Commercial Distribution

  • 10888234000181 ()
0002224

  • Multiple immunohaematology test IVD, control

ImmuAdd - 10888234000167

ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD

ARCHITECT - 00380740138912

ARCHITECT B.R.A.H.M.S PCT Controls
Abbott GmbH
06P2210
In Commercial Distribution

  • 00380740138912 ()
06P2210

  • Procalcitonin (PCT) IVD, calibrator

ARCHITECT - 00380740138905

ARCHITECT B.R.A.H.M.S PCT Calibrators
Abbott GmbH
06P2201
In Commercial Distribution

  • 00380740138905 ()
06P2201

  • Procalcitonin (PCT) IVD, calibrator

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
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