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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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corQC Test System is used for daily quality control evaluation of routine blood bank reagents. It is a two vial set. One vial is a suspension of known red blood cells. The second vial is a known antiserum containing antibodies.
IMMUCOR, INC.
0002400
In Commercial Distribution

  • 10888234000334 ()
0002400

  • Multiple immunohaematology test IVD, control
Bovine Albumin Solution 22% is intended for use as a high protein potentiator in crossmatch, antibody identification and antibody titration procedures. This product is prepared from bovine serum albumin and is the ten (10) vial configuration.
IMMUCOR, INC.
0002327
In Commercial Distribution

  • 10888234000235 ()
0002327

  • Bovine serum albumin (BSA) immunohaematology reagent IVD
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 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 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
The r-Control RBC and PLT consists of red blood cell (RBC) Low & RBC High process controls and platelet (PLT) Low & PLT High process controls. It is intended for use with ADAM-rWBC Kit to monitor the process for enumeration of residual leukocytes in leukocyte reduced RBC and PLT products, including dilution, staining, instrument setup, and white blood cell (WBC) enumeration. For in vitro diagnostic use only.
NanoEnTek, Inc.
ADRC
In Commercial Distribution

  • 08809317541143 ()
ADRC 020

  • White blood cell count IVD, control
It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC HT.
NanoEnTek, Inc.
ADHK-050
In Commercial Distribution

  • 08809317541006 ()
ADHK-050

  • White blood cell count IVD, reagent
The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products.
NanoEnTek, Inc.
ADAM-rWBC HT
In Commercial Distribution

  • 08809317540993 ()
ADAM-rWBC HT

  • White blood cell count IVD, kit, cell count
ADAMII-CD34 Kit provides enumeration of viable CD34+ cells, viable CD45+ cells, and calculates percentage of viable CD34+ cells out of viable CD45+ cells. ADAMII-CD34 Kit can be used for mobilized peripheral blood (MPB) collected in Na-Heparin or EDTA, haematopoietic progenitor cell – apheresis (HPC-A) collected in ACD or ACD+Heparin, fresh cord blood (FCB) collected in CPD, and thawed frozen cord blood (TFCB) collected in CPD and stored with 10% DMSO, 1% Dextran 40.
NanoEnTek, Inc.
CD34K-050
In Commercial Distribution

  • 08809317540634 ()
CD34K-050

  • CD34 cell marker IVD, antibody
ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.
NanoEnTek, Inc.
ADAMII
In Commercial Distribution

  • 08809317540627 ()


  • Haematological cell analyser IVD
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