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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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Zinc PVA Fixative 250ml Each
REMEL, INC.
R21278
In Commercial Distribution

  • 00848838023613 ()
R21278

  • Faecal specimen container IVD, fixative
PS80 Hydrolysis Substrate Conc VL/5ml
REMEL, INC.
R21276
Not in Commercial Distribution

  • 00848838023606 ()
R21276

  • Culture medium control
R21270 R21270 TB Base Digestant BTL/100ml
REMEL, INC.
R21270
Not in Commercial Distribution

  • 00848838023576 ()
R21270

  • Culture medium base ingredient IVD
TB Digestant (4% NaOH) BTL/250ml
REMEL, INC.
R21266
Not in Commercial Distribution

  • 00848838023538 ()
R21266

  • Culture medium base ingredient IVD
R21262 Sodium Citrate (2.94%) BTL/250ml
REMEL, INC.
R21262
Not in Commercial Distribution

  • 00848838023514 ()
R21262

  • Culture medium base ingredient IVD
PVA-Modified Fixative 500ml Each
REMEL, INC.
R21259
Not in Commercial Distribution

  • 00848838023484 ()
R21259

  • Faecal specimen container IVD, fixative
PYR Reagent BTL/25ml
REMEL, INC.
R21258
In Commercial Distribution

  • 00848838023477 ()
R21258

  • Biological stain IVD
R21256 Phosphate Buffer M/15 BTLx10/50ml
REMEL, INC.
R21256
In Commercial Distribution

  • 00848838023460 ()
R21256

  • Culture medium base ingredient IVD
Potassium Tellurite (0.2%) BTL/25ml
REMEL, INC.
R21254
Not in Commercial Distribution

  • 00848838023453 ()
R21254

  • Biological stain IVD
Potassium Hydroxide (KOH) 3% BTL/25ml
REMEL, INC.
R21251
In Commercial Distribution

  • 00848838023446 ()
R21251

  • Biological stain IVD
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