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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 – 25020 Avenue Tibbitts Valencia, CA 91355 – D +1.661.567.0667 P +1.888.UTAK.LAB F +1.661.294.9272 – Book a Meeting with Me https://calendly.com/ahartmann-utak/30min utak.com 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?
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  • Created Nov 24, 2025 03:35 PM
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