Where can I find product instructions and safety information?
Product instructions (Instructions For Use) and product safety information (Safety Data Sheets) for our catalogued products can be found online in our Technical Library 24/7.
Once you’re in the library, it's just a few clicks to get the document that’s right for your lab:
- Select your country from the drop-down menu.
- Select your desired language from the drop-down menu.
All documents are available in English and we are continually expanding our language offerings.
- Type the product’s catalog number in the "Search Catalog Number" field.
As you begin typing, you’ll notice that suggested catalog numbers appear. You can continue typing or click on one of the suggested numbers.
- Click the magnifying glass icon to search for your documents.
- The technical library is designed to provide you the documents applicable to the country in which your lab is located so it’s important to select the correct options when searching for a document. You should not use Instructions for Use intended for another country. Safety Data Sheets are global.
- Don’t know the catalog number? You can find it on your product packaging or on our website. You may also need to refer to the packaging for the lot number to help identify which version of a document applies to your lab.
- If a product is not cleared for sale in the selected country or a document is not available in the selected language, you’ll receive an on-screen message advising that results were not found. Review your search criteria and choose the appropriate options.
- If you have questions about what document to use or cannot find the document you are looking for, please contact Customer Care.
Watch our helpful how-to video to learn more about the Technical Library.
Why choose frozen CRYOcheck™ calibrators, controls, reagents, and diagnostic kits over lyophilized alternatives?
CRYOcheck frozen products:
- do not require reconstitution—reducing preparation time and the risk of reconstitution errors
- are convenient and easy to use
And, CRYOcheck plasmas are more representative of an actual patient sample.
Will CRYOcheck products work on my instrument?
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.
At what temperature should I store my CRYOcheck products?
Storage temperatures vary by product and are noted on product boxes and Instructions For Use (IFU). To ensure product integrity and performance, always store your products at the temperatures recommended by Precision BioLogic.
Frozen products should not be stored in 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.
How should I thaw frozen CRYOcheck products?
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.
To help you get the most from your CRYOcheck frozen products, follow our simple storage and handling guidelines in conjunction with your lab’s standard operating procedures.
Why use CRYOcheck Pooled Normal Plasma instead of an in-house collected pool?
Our normal pooled 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
Is CRYOcheck Pooled Normal Plasma platelet-poor?
Yes. We use a validated process for the preparation of our CRYOcheck Pooled Normal Plasma that ensures all donor plasmas used to make the product are platelet-poor (i.e. < 10,000 platelets/µL).
Is CRYOcheck Pooled Normal Plasma buffered?
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.
How many donors are used to manufacture each lot of CRYOcheck Pooled Normal Plasma?
Each lot of our normal pooled plasma is manufactured from 20 or more carefully screened male and female donors aged 18 to 66.
How is the normality of CRYOcheck Pooled Normal Plasma verified?
All plasmas used in the manufacture of CRYOcheck Pooled Normal Plasma are tested and found negative when screened for lupus anticoagulant. 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 pooled normal plasma we manufacture.
Why am I getting different results than those listed on the Quality Control (QC) Certificate provided with my specific lot number?
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 by phone at 1.800.267.2796 or using our online Contact Form.
How do I convert U/mL to % or vice versa?
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).
Are Precision BioLogic products registered with the U.S. FDA?
Precision BioLogic is registered with the U.S. 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: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
You can search the FDA’s Establishment Registration & Device Listing database online at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
How long has Precision BioLogic been developing frozen diagnostic products?
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.
I'm concerned about ordering frozen products. What assurance do I have that my order will not thaw in transit?
To ensure product integrity, our standard shipping days are Monday to Wednesday. 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.
How much freezer space will I need to store my CRYOcheck products?
Surprisingly little due to our compact packaging.
25-vial box measurements:
- 2.63 x 2.19 x 3.06 inches
- 6.7 x 5.6 x 7.8 cm
80-vial box measurements:
- 2.63 x 2.19 x 9 inches
- 6.7 x 5.6 x 22.9 cm
What is the Customer Portal and how can I gain access?
The Customer Portal is our secure, online customer resource. There you will find lot-specific Quality Control or Assay Certificates, your institution’s order history, and more. You can access the portal by clicking the portal login icon 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, click "Sign-up", complete the form, and click "Submit". If you have difficulty getting a password or logging in, please contact Customer Care for assistance.