Stability testing of in vitro diagnostic reagents

2015 ◽  
Keyword(s):  
Stability Testing ◽  
In Vitro Diagnostic

scholarly journals Stability Testing, Shelf Life and Product Expiration Dating

1998 ◽  
Vol 6 (10) ◽  
pp. 20-21
Author(s):  
Peter A. Takes
Keyword(s):  
Shelf Life ◽  
Laboratory Research ◽  
Stability Testing ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
In Vitro Diagnostic ◽  
Expiration Dating ◽  
Intended Use ◽  
Specific Reagent

Reagents available for laboratory, research, and clinical use are often acquired with a specified expiration date. Yet, many are not, depending on the manufacturer and reagent type. What a manufacturer does is frequency determined by how they label the product.The U.S. Ricd and Drug Administration [FDA] has defined categories by which reagents can he labeled based on their “intended use”. individual reagents (e.g., antibodies) intended for clinical diagnostic laboratory use will be labeled as an in Vitro Diagnostic [IVD] or Analyte Specific Reagent [ASR]. Under these categories, specified expiration dates must be supported by stability testing which establishes the product shelf life.

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