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Clinical Laboratory Reagents: The Regulatory Hurdle

Published online by Cambridge University Press:  14 March 2018

Peter A. Takes
Peter A. Takes*
Affiliation:
Stereotaxis, Inc

Extract

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Today's clinical laboratory has a diversity of reagents and protocols from which to choose: a variety of clinical chemistry reagents, antibodies, and molecular probes, among others. These materials facilitate serum and urine analysis, histology, hematology, cytology, and a host of additional sensitive and specific assays

Regardless of the application, labs may see an array of labeling statements indicating a reagent's general use: "For Laboratory Use Only" [LUO]; "For Research Use Only" [RUO]; "For Investigational Use Only" [IUO]; "For In Vitro Diagnostic Use" [IVD]; and "Analyte Specific Reagent" [ASR]. These preparations are often employed without realizing the course manufacturer's must follow in order to provide reagents, and the reasons for these designations.

Type
Research Article
Information
Microscopy Today , Volume 7 , Issue 7 , September 1999 , pp. 8 - 9
Copyright
Copyright © Microscopy Society of America 1999

References

1) 21 CFR 809.10.Google Scholar
2) Takes, P.A. 1998. What's in a label? Clin Lab News 24(4): 10.Google Scholar
3) Takes, P.A. and Chambers, L.. 1995. In Vitro Diagnostics: The FDA regulatory process. Clin Lab News 21(7):43–44.Google Scholar
4) Federal Register 62:62243-62260, 1997.Google Scholar
5) Takes, P.A. and Murray, G.. 1998. The Analyte Specific Reagent rule - a new set of regulations for labs, manufacturers. Clin Lab News 24(4)-10,Google Scholar