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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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TEG5000 - 10812747018203

STARTER KIT, TEG5000
HAEMONETICS CORPORATION
07-044
In Commercial Distribution

  • 10812747018203 ()


  • Multiple coagulation factor IVD, control

TEG5000 - 10812747018159

PIPETTE KIT, 1000UL
HAEMONETICS CORPORATION
01-097
In Commercial Distribution

  • 10812747018159 ()

  • Total Volume: 1000 Milliliter


  • Coagulation analyser IVD, laboratory

TEG5000 - 10812747018142

PIPETTE KIT, 100UL
HAEMONETICS CORPORATION
01-096
In Commercial Distribution

  • 10812747018142 ()

  • Total Volume: 100 Microliter


  • Coagulation analyser IVD, laboratory

TEG HEMOSTASIS SYSTEM - 10812747018043

CALCIUM CHLORIDE, 0.2M, 5 ML
HAEMONETICS CORPORATION
07-012
In Commercial Distribution

  • 10812747018043 ()

  • Total Volume: 5 Milliliter


  • Calcium chloride coagulation reagent IVD

Pre-Milled Blank - 08800055700021

No Description
ARUM DENTISTRY Co., Ltd.
CIHE039
In Commercial Distribution

  • 08800055700021 ()


  • Dental implant suprastructure, permanent, preformed

CLOTtrac® - 10885074184828

CONTROL 550-01 CLOTTRAC CWB 11L 15BX
MEDTRONIC, INC.
550-01
In Commercial Distribution

  • 10885074184828 ()
  • 00885074184821 ()


  • Multiple coagulation factor IVD, control

Calcium Chloride Solution - 00630414640563

Supplementary Reagent for coagulation tests
Siemens Healthcare Diagnostics Products GmbH
10873872
In Commercial Distribution

  • 00842768018916 ()
  • 00630414640563 ()
10873872

  • Calcium chloride coagulation reagent IVD

Standard Human Plasma - 00630414639772

Standard Human Plasma for the calibration of coagulation and fibrinolysis tests
Siemens Healthcare Diagnostics Products GmbH
10873907
In Commercial Distribution

  • 00842768018893 ()
  • 00630414639772 ()
10873907

  • Multiple coagulation factor IVD, calibrator

ALBA Elution Kit - 05060242477959

The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. It is intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population. This pre-analytical procedure is performed manually. The ALBA Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte
ALBA BIOSCIENCE LIMITED
Z313U
In Commercial Distribution

  • 05060242477959 ()


  • Red cell antibody eluting IVD, kit

Bovine Serum Albumin 22% - 05060242471520

Bovine Serum Albumin 22%.
ALBA BIOSCIENCE LIMITED
Z305U
In Commercial Distribution

  • 05060242471520 ()
  • 05060242471094 ()


  • Bovine serum albumin (BSA) immunohaematology reagent IVD
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