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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Giemsa (Malaria) Stain Buffer 5x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022079 ()
0003550

  • Biological stain IVD
Nocardia/Actinomyces Counterstain 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022062 ()
0003545

  • Biological stain IVD
Nocardia/Actinomyces Decolorizer 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022055 ()
0003544

  • Biological stain IVD
Nocardia/Actinomyces Stain Wash 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022048 ()
0003543

  • Biological stain IVD
Nocardia/Actinomyces Primary Stain 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022031 ()
0003542

  • Biological stain IVD
Thiazine Red Counterstain 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021997 ()
  • 00816085022000 ()
0003536C

  • Biological stain IVD
NPC-67 Neutralizing Buffer 500ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021980 ()


  • Sputum specimen liquefaction/decontamination kit IVD
NPC-67 Neutralizing Buffer 50x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021973 ()
0003940

  • Sputum specimen liquefaction/decontamination kit IVD
NPC-67 Neutralizing Buffer 50x40ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021966 ()
0003939

  • Sputum specimen liquefaction/decontamination kit IVD
NPC-67 Neutralizing Buffer 10x500ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021959 ()
0003942

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC Unitary 3.0% Tray
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021942 ()


  • Sputum specimen liquefaction/decontamination kit IVD
Unitary Specimen Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021867 ()
0003928

  • Sputum specimen liquefaction/decontamination kit IVD
NAC-PAC Unitary 3.0%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021539 ()
  • 00816085021850 ()
0004815

  • Sputum specimen liquefaction/decontamination kit IVD
NALC Tablets 5x10ea
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021782 ()
0003921

  • Sputum specimen liquefaction/decontamination kit IVD
Oxalic Acid 20x5ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021768 ()
0003435

  • Sputum specimen liquefaction/decontamination kit IVD
Kinyoun with Methylene Blue Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021669 ()
0003566

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

  • 00816085021652 ()
0003565

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

  • 00816085021645 ()
0003568

  • Biological stain IVD
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
100% Ethanol
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021508 ()
0003303

  • Biological stain IVD
CONSED
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021492 ()
0004629

  • Faecal parasite specimen concentration kit IVD
PROTO-FIX with CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()


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

  • 00816085021478 ()


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

  • 00816085021461 ()


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

  • 00816085021454 ()


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

  • 00816085021447 ()


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

  • 00816085021430 ()


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

  • 00816085021423 ()


  • Faecal specimen collection kit IVD, home-use
CONSED 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021416 ()
0004628

  • Faecal parasite specimen concentration kit IVD
PROTO-FIX Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021409 ()
0004627

  • Biological stain IVD
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
90% Acid-Ethanol 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021249 ()
0004406

  • Biological stain IVD
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