Frequently Asked Questions

Is UTAK ISO Certified?

Yes, UTAK is currently certified by ISO 13485:2003 under CMDCAS. Click the link to view our Certificate of Registration

What is a matrix or baseline sample?

Matrix samples allow you to screen the starting material, prior to manufacturing, for interference with your test method or analytes of interest that are not tested in our in house ELISA screen. Adding a matrix sample to the order typically adds 1-2 weeks to the manufacturing lead time and can increase the per vial price of the material. Matrix samples are required when the analytes of interest are endogenous to the human body, to determine a baseline reading prior to manufacturing.

Where can I get a CoA?

Our CoAs are provided upon request by emailing welovecontrol@utak.com

Where can I find my product insert / instructions for use?

Stock product inserts and IFUs are available online. Personalized QC inserts and IFUs, however, are available by email, at welovecontrol@utak.com

Can lyophilized products be shipped in ambient temperatures?

Yes. UTAK has conducted a set of tests and studies that provides data that our freeze dried products can be at temperatures between 2°C – 40°C (35 – 104°F) for at least up to 2 weeks without degrading. In cases with the lower range of temperatures the product can last longer than 2 weeks. These studies were conducted as a part of a risk assessment that is done for all UTAK stock products.

Can I freeze reconstituted stock products?

The warranted reconstituted stability for UTAK lyophilized controls will never exceed 25 – 30 days due to the unpredictability of spiked-in analytes in a 100% human biological matrix.
However, if a lyophilized control is thawed / reconstituted and subsequently frozen within 30 minutes, the newly frozen aliquots shall take on the performance attributes of a UTAK frozen control.
UTAK frozen controls retain an 18 month shelf life from their initial freeze date. Therefore, once frozen the aliquots will have an expiration date of 18 months or the shelf life for the newly frozen aliquots cannot exceed the shelf life date printed on the original product insert.

How many freeze thaw cycles can we do with blank matrix?

UTAK does not recommend multiple thaw cycles in regards to Human Blank Matrices. However Human Blank Matrices can withstand a small amount of thaw cycles over a longer period of time. If thawing and aliquoting into smaller amounts, UTAK recommends refreezing the matrix within 72 hours of completion of thawing. This ensures minimal exposure to the matrix.

Can validity controls be shipped in ambient temperatures?

UTAK has conducted a set of tests and studies that provides data that our Validity Control products, part# 17010-17014 can be at temperatures between 2°C – 40°C (35 – 104°F) for at least up to 2 weeks without degrading. In cases with the lower range of temperatures the product can last longer than 2 weeks. These studies were conducted as a part of a risk assessment that is done
for all UTAK stock products

How do we thaw and aliquot blank matrix?

UTAK has conducted a set of tests and studies that provides data that our freeze dried products can be at temperatures between 2°C to 40°C (35 – 104°F) for at least up to 2 weeks without degrading. In cases with the lower range of temperatures the product can last longer than 2 weeks. These studies were conducted as a part of a risk assessment that is done for all UTAK stock products.

Can we thaw and then re-freeze a stock control.

We do not recommend refreezing thawed control material.

How much do your products cost

Pricing information is not available online, please contact UTAK by phone or email.

Is verification the same thing as validation?

No, third party verification is a single data point to show the requested analytes are performing as expected. If this option is chosen, you would still need to validate each lot according to your procedure.

My product isn't performing as expected. Who can I contact about this?

For technical support, please contact UTAK Customer service for support at 1-888-882-5522 or email welovecontrol@utak.com

Can I order online?

Online ordering is not available at this time. To place an order, please call (888) 882-5522, email orders@utak.com, or fax (661) 294-9272 to reach the Control Freaks.

How many analytes can I put in my custom control?

UTAK has manufactured controls with over 100 analytes, feel free to request a quote and we will let you know if it is feasible.

Do you have any peer to peer programs?

We do not have any peer to peer programs at this time.

How much does shipping cost?

We will charge you for shipping at whatever rate our carrier actually charges us for the delivery. If you have your own UPS or FedEx account we are happy to put the shipping charges on your account. Additionally, all frozen shipments will incur a $25.00 USD fee for dry ice (per shipment).

Can I get my frozen shipment out today? (not sure)

We ship frozen items Monday-Wednesday to avoid potential delays over the weekend. If you would like to ship out a frozen item on Thursday or Friday, UTAK will not guarantee the product if it performs out of spec as a result of the delay. Please note, we do not discourage contacting our technical support team and we will replace the product if it is confirmed to be a result of our error.

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