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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 - 00816085024073

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

  • 00816085024059 ()
  • 00816085024073 ()
0004813

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024066

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

  • 00816085024042 ()
  • 00816085024066 ()
0004819

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024059

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

  • 00816085024059 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024042

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

  • 00816085024042 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024035

0.9% Saline 4.0ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024035 ()
0003516

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024028

0.9% Saline 4.5ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024028 ()
0003520

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024011

0.9% Saline 5.0ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024011 ()
0003521

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023861

Bovine Albumin Fraction V 10x10ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023861 ()
0003470

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023847

Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023847 ()
0001352

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023830

Centrifuge Tubes, 15 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023830 ()
0001518

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023823

Centrifuge Tubes, 15 mL, 20 Trays x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023823 ()
0001516

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023809

Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023809 ()
0001350

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023793

Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023793 ()
0003358

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023786

Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023786 ()
X000401

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023779

PRS Parasite Recovery System (Funnel, Triton X, 15 mL Centrifuge Tube, Cap)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023779 ()
0004045

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023762

PRS Parasite Recovery System (Funnel, Triton X, 15 mL Centrifuge Tube, Cap, Pour spout cap)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023762 ()


  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023755

QC1 Gram Negative Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023731 ()
  • 00816085023755 ()
003275

  • Biological stain control IVD

Alpha-Tec Systems - 00816085023700

QC1 Gram Positive Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023748 ()
  • 00816085023700 ()
0003273

  • Biological stain control IVD

Alpha-Tec Systems - 00816085023694

QC1 AFB Negative Slides
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023724 ()
  • 00816085023694 ()
0003271

  • Biological stain control IVD

Alpha-Tec Systems - 00816085023687

QC1 AFB Positive Slide
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023717 ()
  • 00816085023687 ()
0003269

  • Biological stain control IVD

Alpha-Tec Systems - 00816085023670

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

  • 00816085023663 ()
  • 00816085023670 ()
0003371

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085023663

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

  • 00816085023663 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085023656

PARA-PRO fc50
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023656 ()
0004060

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023632

PRS Parasite Recovery System (Filtration units only)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023632 ()
0004044

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023625

Nocardia/Actinomyces Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023625 ()
0003535

  • Biological stain IVD

Alpha-Tec Systems - 00816085023595

Ziehl-Neelsen Carbolfushsin Stain 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023588 ()
  • 00816085023595 ()
0003531C

  • Biological stain IVD

Alpha-Tec Systems - 00816085023571

Auramine O/Rhodamine B Stain 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023564 ()
  • 00816085023571 ()
0003530C

  • Biological stain IVD

Alpha-Tec Systems - 00816085023557

Potassium Permanganate Counterstain 8x250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023557 ()
0003529C

  • Biological stain IVD

Alpha-Tec Systems - 00816085023533

TB Fluorescent Decolorizer 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023526 ()
  • 00816085023533 ()
0003528C

  • Biological stain IVD

Alpha-Tec Systems - 00816085023519

Auramine O Fluorescent Stain 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023502 ()
  • 00816085023519 ()
0003527C

  • Biological stain IVD

Alpha-Tec Systems - 00816085023496

Methylene Blue Counterstain 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023489 ()
  • 00816085023496 ()
0003526C

  • Biological stain IVD

Alpha-Tec Systems - 00816085023472

TB Decolorizer 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023465 ()
  • 00816085023472 ()
0003525C

  • Biological stain IVD

Alpha-Tec Systems - 00816085023458

Kinyoun Carbolfuchsin Stain 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023441 ()
  • 00816085023458 ()
0003524C

  • Biological stain IVD

Alpha-Tec Systems - 00816085023403

MUCOSOL (Cleland's Reagent) 15x10ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023403 ()
0003510

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023373

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

  • 00816085023373 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023366

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

  • 00816085023366 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023359

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

  • 00816085023373 ()
  • 00816085023359 ()
0003499

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023342

M/15 Phosphate Buffer 50x40ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023342 ()
0003496

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023335

XPR-Plus Neutralizing Buffer 50x40ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023335 ()
0003495

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023328

No Description
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023397 ()
  • 00816085023328 ()
0003482

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023311

XPR-Plus Neutralizing Buffer 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023380 ()
  • 00816085023311 ()
0003481

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023304

XPR-Plus Neutralizing Buffer 50x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023304 ()
0003480

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023298

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

  • 00816085023366 ()
  • 00816085023298 ()
0003472

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023281

4% NaOH 250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023281 ()
0003471

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023267

AFB Base Decontamination Reagent (2.0%) 100ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023267 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023250

Sodium Citrate Solution 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023250 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023243

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

  • 00816085023243 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023236

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

  • 00816085023236 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023229

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

  • 00816085023229 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023212

NAC-PAC (3.0%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023212 ()


  • Sputum specimen liquefaction/decontamination kit IVD
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