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U.S. FDA Medical Device Antimicrobial Susceptibility Test Disc Requirements: Antimicrobial Susceptibility Test Disc

FDA Medical Device Definition: An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases

Registrar Corp assists Antimicrobial Susceptibility Test Disc companies with:

  • FDA Antimicrobial Susceptibility Test Disc Establishment Registration
  • FDA Antimicrobial Susceptibility Test Disc Listing
  • FDA Antimicrobial Susceptibility Test Disc Label Requirements and Exceptions
  • FDA Antimicrobial Susceptibility Test Disc Import Information
  • FDA Antimicrobial Susceptibility Test Disc Detentions (Antimicrobial Susceptibility Test Disc Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Antimicrobial Susceptibility Test Disc Manufacturers (Antimicrobial Susceptibility Test Disc Suppliers)
       - Antimicrobial Susceptibility Test Disc Distributors
       - Antimicrobial Susceptibility Test Disc Processors
       - Antimicrobial Susceptibility Test Disc Repackers
       - Antimicrobial Susceptibility Test Disc Relabelers
       - Antimicrobial Susceptibility Test Disc Exporters
       - Antimicrobial Susceptibility Test Disc Importers
For more information about Antimicrobial Susceptibility Test Disc Medical Devices, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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