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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Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HS
Not in Commercial Distribution

  • 00893038002197 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
4917049160
In Commercial Distribution

  • 04015630939138 ()
4917049160

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10431
In Commercial Distribution

  • 05055273217674 ()
CQ10431

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10430
In Commercial Distribution

  • 05055273217667 ()
CQ10430

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution

  • 05055273217650 ()
CQ10429

  • Multiple cardiac marker IVD, control
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10428
In Commercial Distribution

  • 05055273217346 ()
CQ10428

  • Multiple cardiac marker IVD, control
This product is intended for in vitro diagnostic use in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ3259
In Commercial Distribution

  • 05055273201857 ()


  • Multiple cardiac marker IVD, control
This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ3100
In Commercial Distribution

  • 05055273201840 ()


  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
27106X
In Commercial Distribution

  • 00847661004264 ()
27106X

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
27105X
In Commercial Distribution

  • 00847661004257 ()
27105X

  • Multiple cardiac marker IVD, control
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