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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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PROTO-FIX 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021393 ()
0004621

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX with CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()
  • 00816085021386 ()
0004616

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX [2 Vials] /Clean Vial 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021461 ()
  • 00816085021355 ()
0004606C

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX/ETM/Clean Vial 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021454 ()
  • 00816085021348 ()
0004605

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX/Clean Vial 25 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021447 ()
  • 00816085021331 ()
0004604

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX/ETM 25 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021430 ()
  • 00816085021324 ()
0004603

  • Faecal specimen collection kit IVD, home-use
PROTO-FIX 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021423 ()
  • 00816085021317 ()
0004602

  • Sputum specimen liquefaction/decontamination kit IVD
PROTO-FIX 50 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021300 ()
0004600

  • Faecal specimen collection kit IVD, home-use
PRB Pellet Resuspension Buffer 10x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021294 ()
0004512

  • Sputum specimen liquefaction/decontamination kit IVD
PRB Pellet Resuspension Buffer 10x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021287 ()
0004512

  • Sputum specimen liquefaction/decontamination kit IVD
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