Recognized standard
C34 4th Edition
FDA recognition 7-302 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-302 |
|---|---|
| Designation | C34 4th Edition |
| Title | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This guideline provides recommendations for sweat stimulation by pilocarpine iontophoresis (specific precautions are noted), sweat collection in filter paper or gauze (see Appendix A) or in a commercial sweat collector using coiled tubing (see Appendix B), and quantitative chloride measurement. The… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: