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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 - 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

Alpha-Tec Systems - 00816085022567

ETM With CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022673 ()
  • 00816085022567 ()
0003316

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022550

SAF With CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022550 ()
0003312

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022529

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

  • 00816085022529 ()
0003125

  • Biological stain IVD

Alpha-Tec Systems - 00816085022512

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

  • 00816085022512 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022505

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

  • 00816085022505 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022499

PVA (Zn)/10% Formalin (cup) bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022499 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022482

Microvials PVA (Zn) Fix/10% Formalin bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022482 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022475

PVA (Zn) Fixative bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022475 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022468

PVA (Zn)/10% Formalin/Clean Vial bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022468 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022451

PVA (Zn)/10% Formalin/ETM bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022451 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022444

PVA (Zn)/Clean Vial bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022444 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022437

PVA (Zn) Fix/10% Formalin bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022437 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022406

ETM®/PVA (Zn) Fixative/Collection Cup
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022505 ()
  • 00816085022406 ()
0003119

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022376

PVA (Zn) Fixative 500ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022376 ()
0003113

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022369

Microvials PVA (Zn) Fix/10% Formalin 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022482 ()
  • 00816085022369 ()
0003110

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022352

PVA (Zn) Fixative 50 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022475 ()
  • 00816085022352 ()
0003107

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022338

PVA (Zn)/10% Formalin/ETM
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022451 ()
  • 00816085022338 ()
0003105

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022307

PVA (Zn) Fixative 50 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022307 ()
0003101

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022291

AFB Base Decontamination Reagent (2.5%) 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022291 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022284

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

  • 00816085022284 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022277

PVA(Zn)/10% Formalin/ETM Microvials bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022277 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022260

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

  • 00816085022260 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022253

ETM (micro) bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022253 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022246

Giemsa (Malaria) Stain Buffer 250ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022246 ()


  • Biological stain IVD

Alpha-Tec Systems - 00816085022239

NALC Ampules 25x250mg
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022239 ()
43533

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022222

NALC Ampules 5x250mg
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022222 ()
0003916

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022208

Sodium Carbonate 5x150mg
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022208 ()
0003907

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085022192

5% Formalin 3.875L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022192 ()
0003805

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022185

ETM® / Clean Microvials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022185 ()
0003725

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022178

PVA(Zn)/10% Formalin/ETM Microvials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022277 ()
  • 00816085022178 ()
0003724

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022161

PVA (Zn) Fixative Microvials 64 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022161 ()
0003716

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022154

816085022260
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022260 ()
  • 00816085022154 ()
0003712

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022123

ETM Microvials 64 vials
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022123 ()
0003701

  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085022086

Kinyoun Carbolfuchsin Stain 1L
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085022086 ()
0003559

  • Biological stain IVD

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
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