pH Testing

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Looking for guidance regarding pH strip testing complexity. 

3 Replies

Mario,  are you asking if its waived or non-waived?  Its most likely waived but without listing the specific brand and type/kit you're not going to get any definitive answers.

The Manufacturer's literature would state it somewhere, you could also look it up on the FDA's website:
 https://www.accessdata.fda.gov/Scripts/cdrh/cfdocs/cfCLIA/search.cfm#:~:text=Enter%20any%20combination%20of%20fields,Help%20Download%20Files

All qualitative dipstick pH testing is categorized as a waived test:
Attachment.
image.png
 

Ditto on Jeremy's response ... it is most likely waived, and the manufacturers literature should state the complexity.

CMS also maintains a link to the FDA searchable database of testing complexity. It gives you multiple ways to search.

https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/cartegorization

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

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Mario Olivo
5 months ago
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