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U.S. FDA Medical Device Enterovirus Nucleic Acid Assay Requirements: Enterovirus Nucleic Acid Assay

FDA Medical Device Definition: An enterovirus nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of enterovirus ribonucleic acid (RNA) in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus

Registrar Corp assists Enterovirus Nucleic Acid Assay companies with:

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