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Questioning if our QC is clia waved
Nov 24, 2025 03:33 PM
Hello,
Our QC’s are an independent 3rd party QC. We are classified as FDA class 1 Exempt control material. Otherwise referred to as an unassayed QC. The designation of CLIA waved would not apply to a product like ours.
Happy to go into this if you have further questions, but suffice to say we have never seen a lab have an issue during a CLIA audit from the use of our control material.
Thank you,
Andrew Hartmann
Business Development Manager
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25020 Avenue Tibbitts
Valencia, CA 91355
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D +1.661.567.0667
P +1.888.UTAK.LAB
F +1.661.294.9272
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https://calendly.com/ahartmann-utak/30min
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From: Golden Toxicology <staff.goldentoxicology@gmail.com>
Sent: Friday, November 21, 2025 11:02 AM
To: Andrew Hartmann <ahartmann@utak.com>
Subject: Re: Your lab must like our pee!
Thank you for the information, Andrew. Are these controls CLIA-Waived? And if so, is there documentation to show that?