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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 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 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
Hemantigen (Pooled Cells) is used in the detection of unexpected red blood cell blood group antibodies for blood donors. Hemantigen is a single vial pool of equal amounts of reagent red blood cells from two (2) group O donors.
IMMUCOR, INC.
0002223
In Commercial Distribution

  • 10888234000174 ()
0002223

  • Pooled antibody screening reagent red blood cell IVD, antigen
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
No Description
SEPTODONT, INC
01C2080
In Commercial Distribution

  • 00303620000857 ()

  • Weight: 4.5 Gram


  • Dental etching solution
  • Dental composite resin
  • Dentine adhesive
Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
PROMEGA CORPORATION
MD2140
In Commercial Distribution

  • 00849811031717 ()
MD2140

  • Microsatellite instability IVD, kit, nucleic acid technique (NAT)
Growth Hormone 2 Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
511ro
In Commercial Distribution

  • 00850011135808 ()


  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control
AccuTrak Abeta42 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0258
In Commercial Distribution

  • 00850011135792 ()


  • Amyloid B component IVD, control
VALIDATE tTau CSF Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
805re
In Commercial Distribution

  • 00850011135785 ()


  • Tau protein IVD, control
VALIDATE pTau181 CSF Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
804re
In Commercial Distribution

  • 00850011135778 ()


  • Tau protein IVD, control
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