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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 - 00816085022079

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

  • 00816085022079 ()
0003550

  • Biological stain IVD

Alpha-Tec Systems - 00816085022062

Nocardia/Actinomyces Counterstain 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022062 ()
0003545

  • Biological stain IVD

Alpha-Tec Systems - 00816085022055

Nocardia/Actinomyces Decolorizer 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022055 ()
0003544

  • Biological stain IVD

Alpha-Tec Systems - 00816085022048

Nocardia/Actinomyces Stain Wash 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022048 ()
0003543

  • Biological stain IVD

Alpha-Tec Systems - 00816085022031

Nocardia/Actinomyces Primary Stain 1x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022031 ()
0003542

  • Biological stain IVD

Alpha-Tec Systems - 00816085022000

Thiazine Red Counterstain 8x250ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021997 ()
  • 00816085022000 ()
0003536C

  • Biological stain IVD

Alpha-Tec Systems - 00816085021980

NPC-67 Neutralizing Buffer 500ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021980 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021973

NPC-67 Neutralizing Buffer 50x50ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021973 ()
0003940

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021966

NPC-67 Neutralizing Buffer 50x40ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021966 ()
0003939

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021959

NPC-67 Neutralizing Buffer 10x500ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021959 ()
0003942

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021942

NAC-PAC Unitary 3.0% Tray
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021942 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021867

Unitary Specimen Tubes
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021867 ()
0003928

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021850

NAC-PAC Unitary 3.0%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021539 ()
  • 00816085021850 ()
0004815

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021782

NALC Tablets 5x10ea
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021782 ()
0003921

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021768

Oxalic Acid 20x5ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021768 ()
0003435

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021669

Kinyoun with Methylene Blue Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021669 ()
0003566

  • Biological stain IVD

Alpha-Tec Systems - 00816085021652

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

  • 00816085021652 ()
0003565

  • Biological stain IVD

Alpha-Tec Systems - 00816085021645

Auramine O with Potassium Permanganate Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021645 ()
0003568

  • Biological stain IVD

Alpha-Tec Systems - 00816085021638

Auramine O with Thiazine Red Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021638 ()
0003569

  • Biological stain IVD

Alpha-Tec Systems - 00816085021621

OxA Oxalic Acid Reagent tray
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021621 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021614

OxA Oxalic Acid Reagent Kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021621 ()
  • 00816085021614 ()
0004805

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021591

NAC-PAC RED (3.0%) 1x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021591 ()
0004311

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021577

Rapid Auramine O Stain Set Decolorizer/Counterstain 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021577 ()


  • Biological stain IVD

Alpha-Tec Systems - 00816085021560

Rapid Auramine O Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021560 ()
0003570

  • Biological stain IVD

Alpha-Tec Systems - 00816085021546

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

  • 00816085021546 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021539

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

  • 00816085021539 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021522

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

  • 00816085021546 ()
  • 00816085021522 ()
0004817

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021515

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

  • 00816085021515 ()
  • 00816085021539 ()
0004815

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021508

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

  • 00816085021508 ()
0003303

  • Biological stain IVD

Alpha-Tec Systems - 00816085021492

CONSED
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021492 ()
0004629

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085021485

PROTO-FIX with CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021478

PROTO-FIX/PVA (Zn)/ETM bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021478 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021461

PROTO-FIX [2 Vials] /Clean Vial bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021461 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021454

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

  • 00816085021454 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021447

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

  • 00816085021447 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021430

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

  • 00816085021430 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021423

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

  • 00816085021423 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021416

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

  • 00816085021416 ()
0004628

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085021409

PROTO-FIX Stain Set
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021409 ()
0004627

  • Biological stain IVD

Alpha-Tec Systems - 00816085021393

PROTO-FIX 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021393 ()
0004621

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021386

PROTO-FIX with CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()
  • 00816085021386 ()
0004616

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021355

PROTO-FIX [2 Vials] /Clean Vial 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021461 ()
  • 00816085021355 ()
0004606C

  • Faecal specimen collection kit IVD, home-use

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 - 00816085021331

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

  • 00816085021447 ()
  • 00816085021331 ()
0004604

  • 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 - 00816085021317

PROTO-FIX 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021423 ()
  • 00816085021317 ()
0004602

  • Sputum specimen liquefaction/decontamination kit IVD

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 - 00816085021249

90% Acid-Ethanol 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021249 ()
0004406

  • Biological stain IVD
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