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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 - 00816085022697

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

  • 00816085022697 ()
0003336

  • Biological stain IVD

Alpha-Tec Systems - 00816085022680

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

  • 00816085022680 ()
0003335

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022673

ETM With CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022673 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022666

SAF With CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022666 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022659

CONSED Red Diluting Reagent 30ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022659 ()


  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085022642

Giemsa (Malaria) Stain Buffer 125ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022642 ()


  • Biological stain IVD

Alpha-Tec Systems - 00816085022635

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

  • 00816085022635 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022628

ETM® 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022635 ()
  • 00816085022628 ()
0003330

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022581

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

  • 00816085022581 ()
0003325

  • Biological stain IVD

Alpha-Tec Systems - 00816085022574

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

  • 00816085022574 ()
0003324

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022550

SAF With CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022550 ()
0003312

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022307

PVA (Zn) Fixative 50 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022307 ()
0003101

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022277

PVA(Zn)/10% Formalin/ETM Microvials bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022277 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022246

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

  • 00816085022246 ()


  • Biological stain IVD

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 - 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 - 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 - 00816085021225

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

  • 00816085021225 ()
0004404

  • 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 - 00816085021164

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

  • 00816085021164 ()
0004209

  • Biological stain 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

Alpha-Tec Systems - 00816085020952

NAC-PAC RED (2.5%) 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021027 ()
  • 00816085020952 ()
0004305

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020945

NAC-PAC RED (4.0%) 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021010 ()
  • 00816085020945 ()
0004304

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020938

NAC-PAC RED (3.0%) 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020266 ()
  • 00816085020938 ()
0004303

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020921

NAC-PAC RED (2.0%) 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020914 ()
  • 00816085020921 ()
0004302

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020914

NAC-PAC RED (2.0%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020914 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020891

1g Cysteine
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020891 ()
X003457

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020884

.25g Cysteine
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020884 ()
X003441

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020877

NALC tablets 1x10ea
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020877 ()
X000020

  • Sputum specimen liquefaction/decontamination kit IVD
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