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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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ACL ELITE
INSTRUMENTATION LABORATORY COMPANY
00000880311
In Commercial Distribution

  • 08426950453017 ()
00000880311

  • Coagulation analyser IVD, laboratory
HemosIL Wash-R Emulsion 1000 mL
INSTRUMENTATION LABORATORY COMPANY
00020002400
In Commercial Distribution

  • 08426950078944 ()
00020002400

  • Buffered sample diluent IVD
HemosIL Rinse Solution (ACL TOP Family) 4000 mL
INSTRUMENTATION LABORATORY COMPANY
00020009700
Not in Commercial Distribution

  • 08426950075882 ()
00020009700

  • Buffered sample diluent IVD, manual
HemosIL Coagulation Optic Test
INSTRUMENTATION LABORATORY COMPANY
00009758050
In Commercial Distribution

  • 08426950452034 ()
00009758050

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use
ACL ELITE PRO
INSTRUMENTATION LABORATORY COMPANY
00001000311
In Commercial Distribution

  • 08426950451570 ()
00001000311

  • Coagulation analyser IVD, laboratory
HemosIL Special Test Control Level 2
INSTRUMENTATION LABORATORY COMPANY
00020012000
In Commercial Distribution

  • 08426950442189 ()
  • 18426950442186 ()
00020012000

  • Multiple coagulation factor IVD, control
GEM Test ACT-LR Cartridges
INSTRUMENTATION LABORATORY COMPANY
06260040000
Not in Commercial Distribution

  • 08426950088608 ()
  • 18426950088605 ()
06260040000

  • Activated clotting time (ACT) IVD, kit, clotting
GEM Test ACT+ Cartridges
INSTRUMENTATION LABORATORY COMPANY
06260038000
Not in Commercial Distribution

  • 08426950088585 ()
  • 18426950088582 ()
06260038000

  • Activated clotting time (ACT) IVD, kit, clotting
GEM Test APTT Cartridges
INSTRUMENTATION LABORATORY COMPANY
06260034000
Not in Commercial Distribution

  • 08426950088561 ()
  • 18426950088568 ()
06260034000

  • Prothrombin time (PT) IVD, kit, clotting
GEM Test Citrate PT Cartridges
INSTRUMENTATION LABORATORY COMPANY
06260032000
Not in Commercial Distribution

  • 08426950088554 ()
  • 18426950088551 ()
06260032000

  • Prothrombin time (PT) IVD, kit, clotting
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