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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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Remel - 00848838068416

Xpect C. diff Toxin A/B KT/40TST
REMEL, INC.
R24640
In Commercial Distribution

  • 30848838068417 ()
  • 00848838068416 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Remel - 00848838027093

Xpect C. diff Toxin A/B KT/20TST
REMEL, INC.
R24650
In Commercial Distribution

  • 30848838027094 ()
  • 00848838027093 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Status™ COVID-19/Flu Control - 10743816001614

Status™ COVID-19/Flu A&B Control Swab Kit (5 Positive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-511C-00
In Commercial Distribution

  • 10743816001614 ()
BSP-511C-00

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • Influenza A/B virus antigen IVD, control

BioSign Flu A+B Nasal Wash/Aspirate Kit - 10743816001485

BioSign Flu A+B Nasopharyngeal Wash/Aspirate Kit, 50 pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-07
In Commercial Distribution

  • 10743816001485 ()
BSP-510AS-07

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent

Status Flu A+B Nasal Wash/Aspirate Kit - 10743816001416

Status Flu A+B Nasopharyngeal Wash/Aspirate Kit; 44 Pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-04
In Commercial Distribution

  • 10743816001416 ()
BSP-510AS-04

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent

VIROTROL - 03610520530139

VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000538
In Commercial Distribution

  • 03610520530139 ()
12000538

  • Multiple blood-borne virus antigen/antibody IVD, control

VIROTROL - 03610520530146

VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000539
In Commercial Distribution

  • 03610520530146 ()
12000539

  • Multiple blood-borne virus antigen/antibody IVD, control

QUANTA Lite® PBC Screen IgG/IgA ELISA - 08426950594239

1. 1x PBC Screen IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA Low Positive 4. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP PBC Screen IgG/IgA Conjugate, (goat), anti-human IgG/IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704560
In Commercial Distribution

  • 08426950594239 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369236

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369236 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369229

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
1 test/kit
In Commercial Distribution

  • 06974849369229 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical
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