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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 - 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

Alpha-Tec Systems - 00816085023205

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

  • 00816085023205 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023199

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

  • 00816085023243 ()
  • 00816085023199 ()
0003469

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023182

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

  • 00816085023236 ()
  • 00816085023182 ()
0003466

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023175

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

  • 00816085023229 ()
  • 00816085023175 ()
0003465

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023168

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

  • 00816085023267 ()
  • 00816085023168 ()
0003464

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023151

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

  • 00816085023212 ()
  • 00816085023151 ()
0003462

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023144

5% Oxalic Acid 500ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023144 ()
0003460

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023137

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

  • 00816085023250 ()
  • 00816085023137 ()
0003458

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023120

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

  • 00816085023205 ()
  • 00816085023120 ()
0003457

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023113

AFB Base Decontamination Reagent (3.0%) 500ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023113 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023106

AFB Base Decontamination Reagent (3.0%)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023113 ()
  • 00816085023106 ()
0003455

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023090

AFB Base Decontamination Reagent (4.0%) 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023090 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023076

MYCO-PAC 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023076 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023069

MYCO-PAC 5x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023076 ()
  • 00816085023069 ()
0003453

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023052

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

  • 00816085023052 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023038

NALC Bulk 50g
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023038 ()
0003450

  • Sputum specimen liquefaction/decontamination kit IVD
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