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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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PRO-CLEAR 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022697 ()
0003336

  • Biological stain IVD
10% Formalin, Buffered 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022680 ()
0003335

  • Faecal specimen collection kit IVD, home-use
ETM With CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022673 ()


  • Faecal specimen collection kit IVD, home-use
SAF With CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022666 ()


  • Faecal specimen collection kit IVD, home-use
CONSED Red Diluting Reagent 30ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022659 ()


  • Faecal parasite specimen concentration kit IVD
Giemsa (Malaria) Stain Buffer 125ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022642 ()


  • Biological stain IVD
ETM bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022635 ()


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

  • 00816085022635 ()
  • 00816085022628 ()
0003330

  • Faecal specimen collection kit IVD, home-use
Giemsa (Malaria) Stain Buffer 5x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022581 ()
0003325

  • Biological stain IVD
10% Formalin, Microvials 64 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022574 ()
0003324

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

  • 00816085022550 ()
0003312

  • Faecal specimen collection kit IVD, home-use
PVA (Zn) Fixative 50 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022307 ()
0003101

  • Faecal specimen collection kit IVD, home-use
PVA(Zn)/10% Formalin/ETM Microvials bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022277 ()


  • Faecal specimen collection kit IVD, home-use
Giemsa (Malaria) Stain Buffer 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022246 ()


  • Biological stain IVD
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/ETM 25 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021430 ()
  • 00816085021324 ()
0004603

  • Faecal specimen collection kit IVD, home-use
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
100% Ethanol 3.875L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021225 ()
0004404

  • Biological stain IVD
95% Ethanol 3.875L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021188 ()
0004213

  • Biological stain IVD
Giemsa (Malaria) Stain 250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021164 ()
0004209

  • Biological stain IVD
NAC-PAC RED (4.0%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021058 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (2.0%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021041 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (2.5%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021034 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (2.5%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021027 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (4.0%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021010 ()


  • Sputum specimen liquefaction/decontamination kit IVD
Centrifuge Tubes and Caps, 15 mL
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021003 ()
0004049

  • Faecal parasite specimen concentration kit IVD
NAC-PAC RED (3.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021065 ()
  • 00816085020990 ()
0004309

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (4.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021058 ()
  • 00816085020983 ()
0004308

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (2.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021041 ()
  • 00816085020976 ()
0004307

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (2.5%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021034 ()
  • 00816085020969 ()
0004306

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (2.5%) 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021027 ()
  • 00816085020952 ()
0004305

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (4.0%) 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021010 ()
  • 00816085020945 ()
0004304

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (3.0%) 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020266 ()
  • 00816085020938 ()
0004303

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (2.0%) 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020914 ()
  • 00816085020921 ()
0004302

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC RED (2.0%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020914 ()


  • Sputum specimen liquefaction/decontamination kit IVD
1g Cysteine
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020891 ()
X003457

  • Sputum specimen liquefaction/decontamination kit IVD
.25g Cysteine
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020884 ()
X003441

  • Sputum specimen liquefaction/decontamination kit IVD
NALC tablets 1x10ea
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020877 ()
X000020

  • Sputum specimen liquefaction/decontamination kit IVD
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