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U.S. FDA Medical Device Clinical Multiplex Test Instrumentation Requirements: Clinical Multiplex Test Instrumentation

FDA Medical Device Definition: A clinical multiplex test systems instrumentation is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals

Registrar Corp assists Clinical Multiplex Test Instrumentation companies with:

  • FDA Clinical Multiplex Test Instrumentation Establishment Registration
  • FDA Clinical Multiplex Test Instrumentation Listing
  • FDA Clinical Multiplex Test Instrumentation Label Requirements and Exceptions
  • FDA Clinical Multiplex Test Instrumentation Import Information
  • FDA Clinical Multiplex Test Instrumentation Detentions (Clinical Multiplex Test Instrumentation Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Clinical Multiplex Test Instrumentation Manufacturers (Clinical Multiplex Test Instrumentation Suppliers)
       - Clinical Multiplex Test Instrumentation Distributors
       - Clinical Multiplex Test Instrumentation Processors
       - Clinical Multiplex Test Instrumentation Repackers
       - Clinical Multiplex Test Instrumentation Relabelers
       - Clinical Multiplex Test Instrumentation Exporters
       - Clinical Multiplex Test Instrumentation Importers
For more information about Clinical Multiplex Test Instrumentation 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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