Frequently Asked Questions - General

Precision BioLogic is registered with the FDA and our CRYOcheck medical devices are listed with the FDA as part of our registration. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the United States’ ability to prepare for and respond to public health emergencies.

For more information on the FDA’s “Device Registration and Listing” requirements, please visit: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/default.htm.

You can search the FDA’s Establishment Registration & Device Listing database online at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm.

We’ve been developing our integrated line of high-quality, frozen controls, calibrators, and reagents - the CRYOcheck brand - since 1992. In our effort to expand our product base, we’ve since introduced in vitro diagnostic products.

All of our CRYOcheck products are packaged on dry ice in Styrofoam boxes and couriered overnight. We include a temperature indicator tag in each shipment to ensure that the temperature in the shipping container has not risen to a level that could compromise the products. We also carefully track all shipments while in transit and notify you once your order has arrived.

Surprisingly little due to our compact packaging. The following table outlines space required to keep your annual order (various quantities) of a single lot number in your freezer.

25-vial box:

  • 2.63 x 2.19 x 3.06 inches
  • 6.7 x 5.6 x 7.8 cm

80-vial box:

  • 2.63 x 2.19 x 9 inches
  • 6.7 x 5.6 x 22.9 cm

The Customer Portal is our online customer resource. There you will find Quality Control certificates, your institution’s order history and more. You can access the portal by clicking the login icon Portal Login Symbol located at the top and bottom of each page of our website or going to my.precisionbiologic.com.

To sign up for access, go to the portal, enter your work email address and click “Get Password”. If you have difficulty getting a password or logging in, please contact us for assistance.