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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 - 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

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

Alpha-Tec Systems - 00816085020853

Ziehl-Neelsen Carbolfuchsin Stain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020853 ()
0003531

  • Biological stain IVD

Alpha-Tec Systems - 00816085020846

Methylene Blue Counterstain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020846 ()
0003526

  • Biological stain IVD

Alpha-Tec Systems - 00816085020839

TB Decolorizer 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020839 ()
0003525

  • Biological stain IVD

Alpha-Tec Systems - 00816085020822

Kinyoun Carbolfuchsin Stain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020822 ()
0003524

  • Biological stain IVD

Alpha-Tec Systems - 00816085020815

Thiazine Red Counterstain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020815 ()
0003536

  • Biological stain IVD

Alpha-Tec Systems - 00816085020808

Auramine O Rhodamine B Stain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020808 ()
0003530

  • Biological stain IVD

Alpha-Tec Systems - 00816085020792

Potassium Permanganate Stain 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020792 ()
0003529

  • Biological stain IVD

Alpha-Tec Systems - 00816085020785

TB Fluorescent Decolorizer 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020785 ()
0003528

  • Biological stain IVD

Alpha-Tec Systems - 00816085020778

Auramine O Stain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020778 ()
0003527

  • Biological stain IVD

Alpha-Tec Systems - 00816085020716

M/15 Phosphate Buffer 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020716 ()
X003442

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020709

M/15 Phosphate Buffer 500ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020709 ()
X003451

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020655

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

  • 00816085020655 ()
0003359

  • Biological stain IVD

Alpha-Tec Systems - 00816085020631

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

  • 00816085020266 ()
  • 00816085020631 ()
0004303

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020624

CELL-BOND Slide, 1 Red well, no background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023878 ()
  • 00816085020624 ()
0003223

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020617

Parasitology Stain QC Slides (+/-)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020228 ()
  • 00816085020617 ()
0003262

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020600

CELL-BOND Slides, 3 black wells
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023885 ()
  • 00816085020600 ()
0003258

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020594

CELL-BOND Slides, no wells or background
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023892 ()
  • 00816085020594 ()
0003257

  • General specimen microscopy slide IVD, single-use

Alpha-Tec Systems - 00816085020587

Cryptosporidium QC Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020198 ()
  • 00816085020587 ()
0003256

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020570

PROTO-FIX QC Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020181 ()
  • 00816085020570 ()
0003255

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020563

Zn PVA QC Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020174 ()
  • 00816085020563 ()
0003251

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020556

Zn PVA QC Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020174 ()
  • 00816085020556 ()
0003254

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020549

Nocardia Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020167 ()
  • 00816085020549 ()
0003248

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020532

AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020150 ()
  • 00816085020532 ()
0003247

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020525

AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020143 ()
  • 00816085020525 ()
0003245

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020518

AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020136 ()
  • 00816085020518 ()
0003240

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020501

AFB Stain Control Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020136 ()
  • 00816085020501 ()
0003243

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020495

Gram Stain Control Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020129 ()
  • 00816085020495 ()
0003238

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020488

Gram Stain Control Slides With 3 Patient Wells
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020112 ()
  • 00816085020488 ()
0003235

  • Biological stain control IVD

Alpha-Tec Systems - 00816085020471

Gram Stain Control Slides With 3 Patient Wells
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020112 ()
  • 00816085020471 ()
0003236

  • Biological stain control IVD
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