Frequently Asked Questions

Technical

CRYOcheck frozen products:

  • do not require reconstitution—reducing preparation time and the risk of reconstitution errors
  • plasmas are more representative of an actual patient sample
  • are convenient and easy to use

CRYOcheck plasma-based products are engineered to be as close to the patient sample as possible. We have hundreds of customers using a broad range of instrumentation including photo-optical, mechanical, and nephelometric clot detection systems as well as manual methods. Instrument-specific protocols are available for our diagnostic reagents and kits on a number of common coagulation analyzers.

You must store CRYOcheck products in a -40 to -80 °C freezer in order to ensure that product quality is not compromised. CRYOcheck Clot C™ and CRYOcheck Clot S™ are exceptions and must be stored at -70 °C or below. You should never use a frost-free freezer, as they are engineered to cycle through frequent temperature fluctuations. For your convenience, we provide you with an ice scraper to help remove the frost in your freezer.

We provide timers, foam “floaties” and thawing instructions to make preparation and use of our CRYOcheck products easy and convenient. It is critical to thaw frozen CRYOcheck products using a 37 °C waterbath for the time indicated in the instructions. DO NOT thaw CRYOcheck products in a heating block or at room temperature. If you do not have a waterbath, you can make your own using a glass beaker and thermometer—if you’re using this method, the water in the beaker must remain at 37 °C for the duration of the thawing process.

CRYOcheck Pooled Normal Plasma:

  • is flash-frozen—giving faster, more precise results and increased productivity
  • has 24 hour stability once thawed (if refrigerated at 2 to 8 °C) and two-year expiry dating from date of manufacture, giving you greater convenience
  • is comprised of platelet-poor plasmas from 20 or more carefully screened male and female donors aged 18 to 66, resulting in a high-quality, versatile product
  • is screened negative for FDA-required tests

Yes. We use a validated process for the preparation of CRYOcheck Pooled Normal Plasma that ensures all donor plasmas used to make the product are platelet-poor (i.e. < 10,000 platelets/µL).

CRYOcheck Pooled Normal Plasma is buffered with HEPES buffer to a final concentration of 0.01M. This product is ideal for assays requiring 37 °C incubations such as Bethesda inhibitors or incubated mixing studies.

Each lot of CRYOcheck Pooled Normal Plasma is manufactured from 20 or more carefully screened male and female donors aged 18 to 66.

All plasmas used in the manufacture of CRYOcheck Pooled Normal Plasma are tested and found negative when screened for Lupus Anticoagulants. Each lot number has been verified to be normal for factors II, V, VII, VIII, IX, X, XI, and XII; and they have PTs, APTTs and fibrinogen in the normal range. CRYOcheck Pooled Normal Plasma is manufactured from 20 or more donors. We provide (by customer request) quality documentation verifying the factor levels for every lot of CRYOcheck Pooled Normal Plasma we manufacture.

The values provided are specific to the particular analytical method indicated. You should establish your own QC ranges that are specific to your instrument and reagent. If you are having difficulties establishing your own QC ranges, please contact our Technical Support staff at 1.800.267.2796 for assistance.

To convert U/mL to %, multiply the U/mL by 100. For example, 1.20 U/mL converts to 120% (1.20 x 100 = 120).

To convert % to U/mL, multiply the % by 0.01 U/mL. For example, 260% converts to 2.60 U/mL (260 x 0.01 U/mL = 2.60 U/mL).

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.