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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Cardiac Control Complete +TnT level 3
CLINIQA CORPORATION
91492
In Commercial Distribution

  • 00817238011629 ()


  • Multiple cardiac marker IVD, control
Cardiac Control Complete +TnT level 2
CLINIQA CORPORATION
91491
In Commercial Distribution

  • 00817238011612 ()


  • Multiple cardiac marker IVD, control
Cardiac Control Complete +TnT level 1
CLINIQA CORPORATION
91490
In Commercial Distribution

  • 00817238011605 ()


  • Multiple cardiac marker IVD, control
LQC Cardiac Control CS, mini pack
CLINIQA CORPORATION
91449
In Commercial Distribution

  • 00817238011520 ()


  • Multiple cardiac marker IVD, control
LQC Cardiac Control CS, Tri-level kit
CLINIQA CORPORATION
91444
In Commercial Distribution

  • 00817238011513 ()


  • Multiple cardiac marker IVD, control
CARDIAC MARKER CONTROL TRI-LVL (min-pack)
CLINIQA CORPORATION
91489
Not in Commercial Distribution

  • 00817238010097 ()


  • Multiple cardiac marker IVD, control
CARDIAC MARKER CONTROL TRI-LEVEL
CLINIQA CORPORATION
91484
In Commercial Distribution

  • 00817238010080 ()


  • Multiple cardiac marker IVD, control
CARDIAC MARKER CONTROL +TnI Level 3
CLINIQA CORPORATION
91483
In Commercial Distribution

  • 00817238010073 ()


  • Multiple cardiac marker IVD, control
Liquid QC Cardiac Marker Control +TnI Level 1
CLINIQA CORPORATION
91481
In Commercial Distribution

  • 00817238010059 ()


  • Multiple cardiac marker IVD, control
LiniCAL Cardiac CalVer for Abbott Systems, Level A LiniCAL Cardiac CalVer for Abbott Systems, Level B LiniCAL Cardiac CalVer for Abbott Systems, Level C LiniCAL Cardiac CalVer for Abbott Systems, Level D LiniCAL Cardiac CalVer for Abbott Systems, Level E
CLINIQA CORPORATION
98602
Not in Commercial Distribution

  • 00817238010028 ()


  • Multiple cardiac marker IVD, control
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1066x
In Commercial Distribution

  • 00867556000195 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1065
In Commercial Distribution

  • 00867556000188 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1066
In Commercial Distribution

  • 00867556000157 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444895
In Commercial Distribution

  • 00842768013898 ()
  • 00630414003863 ()
RF520

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444904
In Commercial Distribution

  • 00842768013829 ()
  • 00630414003924 ()
RF420

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma.
BIOMERIEUX SA
30421-01
Not in Commercial Distribution

  • 03573026161613 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 Tests
Siemens Healthcare Diagnostics Inc.
10464339
In Commercial Distribution

  • 00842768027918 ()
  • 00630414005577 ()
K3032

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Appsync Body Composition Scale (BB&B)
Greater Goods
0341
In Commercial Distribution

  • 10875011003411 ()
  • 00875011003414 ()


  • Stand-on floor scale, electronic
SILK BB 3/0 18" C6-PEARSON
Surgical Specialties México, S. de R.L. de C.V.
PL784B
In Commercial Distribution

  • 10848782005724 ()
  • 00848782005727 ()

  • 3-0 USP


  • Silk suture
SILK BB 4/0 18" C6-PEARSON
Surgical Specialties México, S. de R.L. de C.V.
PL781B
In Commercial Distribution

  • 10848782005717 ()
  • 00848782005710 ()

  • 4-0 USP


  • Silk suture
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