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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 (Weak) - 10888234000211

Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
IMMUCOR, INC.
0002227
In Commercial Distribution

  • 10888234000211 ()
0002227

  • Multiple immunohaematology test IVD, control

Checkcell (Weak) - 10888234000204

Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) 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.
0002226
In Commercial Distribution

  • 10888234000204 ()
0002226

  • Multiple immunohaematology test IVD, control

Checkcell - 10888234000198

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 three (3) vial configuration.
IMMUCOR, INC.
0002225
In Commercial Distribution

  • 10888234000198 ()
0002225

  • Multiple immunohaematology test IVD, control

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

CompoGuard Complete (NA) - 04086000860765

Device, Blood Mixing and Weighing
Fresenius Kabi AG
9029661
In Commercial Distribution

  • 04086000860765 ()
9029661

  • Blood donation rocker

CompoGuard Data (NA) - 04086000860758

Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029651
In Commercial Distribution

  • 04086000860758 ()
9029651

  • Blood donation rocker

CompoGuard Basic (NA) - 04086000860741

Device, Blood Mixing And Weighing
Fresenius Kabi AG
9029641
In Commercial Distribution

  • 04086000860741 ()
9029641

  • Blood donation rocker

CompoMaster Net G5 - 04086000860581

The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation.
Fresenius Kabi AG
9025571
In Commercial Distribution

  • 04086000860581 ()
9025571

  • Blood component separator, automated

CompoMat G5 - 04086000860475

The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation. The CompoMat G5 can carry out almost all preparation methods and handle almost all blood bag systems, such as conventional double, triple and quadruple blood bag systems.
Fresenius Kabi AG
9025561
In Commercial Distribution

  • 04086000860475 ()
9025561

  • Blood component separator, automated
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