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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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Auramine O with Thiazine Red Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021638 ()
0003569

  • Biological stain IVD
OxA Oxalic Acid Reagent tray
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021621 ()


  • Sputum specimen liquefaction/decontamination kit IVD
OxA Oxalic Acid Reagent Kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021621 ()
  • 00816085021614 ()
0004805

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (3.0%) 1x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021591 ()
0004311

  • Sputum specimen liquefaction/decontamination kit IVD
Rapid Auramine O Stain Set Decolorizer/Counterstain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021577 ()


  • Biological stain IVD
Rapid Auramine O Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021560 ()
0003570

  • Biological stain IVD
NAC-PAC EA3 (2.5%) tray w/ NALC tablets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021546 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (3.0%) tray w/ NALC tablets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021539 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (2.5%) w/ NALC tablets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021546 ()
  • 00816085021522 ()
0004817

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC EA3 (3.0%) w/ NALC tablets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021515 ()
  • 00816085021539 ()
0004815

  • Sputum specimen liquefaction/decontamination kit IVD
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