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U.S. FDA Medical Device B-Type Natriuretic Peptide Test System Requirements: B-Type Natriuretic Peptide Test System

FDA Medical Device Definition: The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure

Registrar Corp assists B-Type Natriuretic Peptide Test System companies with:

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


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