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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 - 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

Alpha-Tec Systems - 00816085023021

M/15 Phosphate Buffer 64x10ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023021 ()
0003449

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023014

Bromothymol Blue Solution 30ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023014 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023007

Bromothymol Blue Solution
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023014 ()
  • 00816085023007 ()
0003448

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022994

5% Oxalic Acid 125ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022994 ()
0003447

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022987

NALC Bulk 100g
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022987 ()
0003446

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022963

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

  • 00816085022963 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022956

AFB Base Decontamination Reagent (2.0%) 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022956 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022932

M/15 Phosphate Buffer 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022932 ()
0003442

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022925

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

  • 00816085022963 ()
  • 00816085022925 ()
0003441

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022918

M/15 Phosphate Buffer 50x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022918 ()
0003440

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022901

4 % Sulfuric Acid Solution 125ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022901 ()
0003439

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022871

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

  • 00816085022871 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022864

Sodium Hydroxide Solution (4%)
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022871 ()
  • 00816085022864 ()
0003436

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022857

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

  • 00816085022857 ()
0003367

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022840

Clean Collection Vials 50 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022840 ()
0003366

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022833

SAF Fixative 50 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022833 ()
0003363

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022826

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

  • 00816085022826 ()
0003362

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022819

Cryptosporidium Decolorizer/Counterstain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022819 ()


  • Biological stain IVD

Alpha-Tec Systems - 00816085022802

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

  • 00816085022802 ()


  • Biological stain IVD

Alpha-Tec Systems - 00816085022789

95% Ethanol 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022789 ()
0003356

  • Biological stain IVD

Alpha-Tec Systems - 00816085022765

Wheatley's Trichrome Stain 500ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022765 ()
0003351

  • Biological stain IVD

Alpha-Tec Systems - 00816085022758

90% Acid-Ethanol 500ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022758 ()
0003350

  • Biological stain IVD

Alpha-Tec Systems - 00816085022734

Ethyl Acetate 500ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022734 ()
0003344

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085022703

10% Formalin, Buffered bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022703 ()


  • Faecal specimen collection kit IVD, home-use

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
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