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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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Alpha-Tec Systems - 00816085021645

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

  • 00816085021645 ()
0003568

  • Biological stain IVD

Alpha-Tec Systems - 00816085021638

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

  • 00816085021638 ()
0003569

  • Biological stain IVD

Alpha-Tec Systems - 00816085021621

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

  • 00816085021621 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021614

OxA Oxalic Acid Reagent Kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021621 ()
  • 00816085021614 ()
0004805

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021591

NAC-PAC RED (3.0%) 1x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021591 ()
0004311

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021577

Rapid Auramine O Stain Set Decolorizer/Counterstain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021577 ()


  • Biological stain IVD

Alpha-Tec Systems - 00816085021560

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

  • 00816085021560 ()
0003570

  • Biological stain IVD

Alpha-Tec Systems - 00816085021546

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

  • 00816085021546 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021539

NAC-PAC EA3 (3.0%) tray w/ NALC tablets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021539 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021522

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

Alpha-Tec Systems - 00816085021515

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

Alpha-Tec Systems - 00816085021508

100% Ethanol
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021508 ()
0003303

  • Biological stain IVD

Alpha-Tec Systems - 00816085021492

CONSED
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021492 ()
0004629

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085021485

PROTO-FIX with CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021478

PROTO-FIX/PVA (Zn)/ETM bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021478 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021461

PROTO-FIX [2 Vials] /Clean Vial bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021461 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021454

PROTO-FIX/ETM/Clean Vial bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021454 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021447

PROTO-FIX/Clean Vial bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021447 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021430

PROTO-FIX/ETM bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021430 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021423

PROTO-FIX bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021423 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021416

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

  • 00816085021416 ()
0004628

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085021409

PROTO-FIX Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021409 ()
0004627

  • Biological stain IVD

Alpha-Tec Systems - 00816085021393

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

  • 00816085021393 ()
0004621

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021386

PROTO-FIX with CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()
  • 00816085021386 ()
0004616

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021355

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

Alpha-Tec Systems - 00816085021348

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

Alpha-Tec Systems - 00816085021331

PROTO-FIX/Clean Vial 25 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021447 ()
  • 00816085021331 ()
0004604

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021324

PROTO-FIX/ETM 25 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021430 ()
  • 00816085021324 ()
0004603

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021317

PROTO-FIX 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021423 ()
  • 00816085021317 ()
0004602

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021300

PROTO-FIX 50 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021300 ()
0004600

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021294

PRB Pellet Resuspension Buffer 10x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021294 ()
0004512

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021287

PRB Pellet Resuspension Buffer 10x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021287 ()
0004512

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021249

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

  • 00816085021249 ()
0004406

  • Biological stain IVD

Alpha-Tec Systems - 00816085021225

100% Ethanol 3.875L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021225 ()
0004404

  • Biological stain IVD

Alpha-Tec Systems - 00816085021195

70% Ethanol 3.875L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021195 ()
0004216

  • Biological stain IVD

Alpha-Tec Systems - 00816085021188

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

  • 00816085021188 ()
0004213

  • Biological stain IVD

Alpha-Tec Systems - 00816085021171

90% Ethanol 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021171 ()
0004210

  • Biological stain IVD

Alpha-Tec Systems - 00816085021164

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

  • 00816085021164 ()
0004209

  • Biological stain IVD

Alpha-Tec Systems - 00816085021157

Methylene Blue Phosphate Pre-Stain 250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021157 ()
0004208

  • Biological stain IVD

Alpha-Tec Systems - 00816085021065

NAC-PAC RED (3.0%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021065 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021058

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

  • 00816085021058 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021041

NAC-PAC RED (2.0%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021041 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021034

NAC-PAC RED (2.5%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021034 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021027

NAC-PAC RED (2.5%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021027 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021010

NAC-PAC RED (4.0%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021010 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021003

Centrifuge Tubes and Caps, 15 mL
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021003 ()
0004049

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085020990

NAC-PAC RED (3.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021065 ()
  • 00816085020990 ()
0004309

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020983

NAC-PAC RED (4.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021058 ()
  • 00816085020983 ()
0004308

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020976

NAC-PAC RED (2.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021041 ()
  • 00816085020976 ()
0004307

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020969

NAC-PAC RED (2.5%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021034 ()
  • 00816085020969 ()
0004306

  • Sputum specimen liquefaction/decontamination kit IVD
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