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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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AEmA (anti-endomysial) Monkey Esophagus distal 96 Test Kit
SCIMEDX CORPORATION
6001-96-ESD
In Commercial Distribution

  • 00813545027087 ()
6001-96-ESD

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
AEmA (anti-endomysial) Monkey Esophagus distal 48 Test Kit
SCIMEDX CORPORATION
6001-48-ESD
In Commercial Distribution

  • 00813545027070 ()
6001-48-ESD

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
Monkey Esophagus distal 8 Well Slide (each)
SCIMEDX CORPORATION
0608-ESD
In Commercial Distribution

  • 00813545026714 ()
0608-ESD

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
Monkey Esophagus distal 4 Well Slide (each)
SCIMEDX CORPORATION
0604-ESD
In Commercial Distribution

  • 00813545026707 ()
0604-ESD

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
5396EL
In Commercial Distribution

  • 00813545022815 ()
5396EL

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
5348EL
In Commercial Distribution

  • 00813545022785 ()
5348EL

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
5308E
In Commercial Distribution

  • 00813545022754 ()
5308E

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
5301E
In Commercial Distribution

  • 00813545022693 ()
5301E

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
1296LA
In Commercial Distribution

  • 00813545022006 ()
1296LA

  • Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay
  • Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay
  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
  • Smooth muscle antibody IVD, kit, fluorescent immunoassay
For use with the GLUCOCARD W Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly.
ARKRAY USA, INC.
510005
In Commercial Distribution

  • 00015482510053 ()


  • Glucose IVD, control
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