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U.S. FDA Medical Device Analyte Specific Reagents Requirements


FDA Medical Device Definition: Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.

Registrar Corp assists Analyte Specific Reagents companies with:

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






 
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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