Technical FAQs
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Why do people choose frozen CRYOcheck calibrators, controls, reagents, and diagnostic kits over lyophilized alternatives?
- They do not require reconstitution - reducing preparation time and the risk of reconstitution errors
- Plasmas are more representative of an actual patient sample
- They are convenient
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- Why would I consider using CRYOcheck Pooled Normal Plasma instead of my own, in-house collected pool?
CRYOcheck Pooled Normal Plasma:
- is fresh-frozen - giving faster, more accurate results and increased productivity
- has 24 hour stability once thawed (if refrigerated at 2 to 8°C), and 2-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
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Is CRYOcheck Pooled Normal Plasma platelet-poor?
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).
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At what temperature should I store my CRYOcheck products?
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 APCR 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.
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How should I thaw frozen CRYOcheck products?
We provide timers, '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.
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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 at 1.800.267.2796 for assistance.
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How do I convert U/mL to % or vice versa?
To convert U/mL to %, multiply the U/mL by 100
Ex. 1.20 U/mL converts to 120% (1.20 x 100 = 120)
To convert % to U/mL multiply the % by 0.01 U/mL
Ex. 260% converts to 2.60 U/mL (260 x 0.01 U/mL = 2.60 U/mL)
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How many donors are used to manufacture each lot of CRYOcheck Pooled Normal Plasma?
Each lot of CRYOcheck Pooled Normal Plasma is manufactured from 20 or more carefully screened male and female donors aged 18 to 66.
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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 LA and APCR. Each lot number has been verified to be normal for factors II, V, VII, VIII, IX, X, XI, and XII; and they have PTs and APTTs 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.
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Do you supply an MSDS for you products?
Products marketed by Precision BioLogic are classified as Medical Devices within the US Food and Drugs Act (FDA) and Health Canada's Therapeutic Product Directorate (TPD) and are, therefore, exempt from the WHMIS requirement to have an MSDS provided. For your documentation, you may download the following declaration from our Regulatory Affairs Manager. You will need Adobe Acrobat Reader to open this document. Precision BioLogic supports laboratory safe practices and provides product handling instructions within the Direction Insert supplied with each product.
Download MSDS Declaration
Download Adobe® Acrobat® Reader®
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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.
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General FAQs
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How can I place an order for your products?
To place an order, you can contact a member of our Customer Service team at 1.800.267.2796.
Alternatively, you can place an order by filling out our Fax Order Form and sending it to us at 1.800.267.0796 or by emailing us at customerservice@precisionbiologic.com.
If this is your first time ordering from us, please note that we will need the following information to process your order:
- Product name
- Catalog number (please refer to our Products section)
- Quantity and format required
- Contact name and information
- The name of your organization
- Shipping Address
- Billing Address
- EIN (employer identification number) - if in the US
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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 numerous new in vitro diagnostic products, including our new line of clot-based diagnostic kits and the CHROMOcheck line of assays.
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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.
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What is the Precision BioLogic Gold Standard Family of Assayed Plasmas?
The Precision BioLogic Gold Standard Family of Assayed Plasmas is composed of four CRYOcheck products. Each product is assayed for 20 or more hemostasis analytes using international reference standards (where available).
Members of the Gold Standard Family of Assayed Plasmas include calibration plasma (CRYOcheck Normal Reference Plasma), a normal control (CRYOcheck Reference Control Normal), a borderline abnormal control (CRYOcheck Abnormal 1 Reference Control), and a pathological abnormal control (CRYOcheck Abnormal 2 Reference Control).
Twenty or more carefully screened donors are used to manufacture each lot number of product in this family. Donors are a mix of males and females between the ages of 18 and 66.
This family of products allows you to rely on a single product line to provide confidence in the calibration and quality control of your quantitative assays.
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I'm concerned about ordering frozen products. What assurance do I have that my order will not thaw in transit?
All of our CRYOcheck products are packaged on dry ice in styrofoam boxes and couriered overnight. While in transit, we carefully track all shipments and call our customers to confirm that their order has arrived. As well, 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.
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How much freezer space will I need to store my CRYOcheck products?
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:
- 3 1/8 inches x 2 5/8 inches x 2 1/4 inches
- 8 cm x 6.7 cm x 5.6 cm
80-vial box:
- 9 inches x 2 5/8 inches x 2 1/4 inches
- 23 cm x 6.7 cm x 5.6 cm
| Number of Boxes |
Box Size |
| |
25-vial |
80-vial |
| 1 |
18.5 inches3 or 300 cm3 |
53 inches3 or 863 cm3 |
| 10 |
0.11 feet3 or 0.003 m3 |
0.31 feet3 or 0.009 m3 |
| 20 |
0.22 feet3 or0.006 m3 |
0.62 feet3 or 0.018 m3 |
| 25 |
0.275 feet3 or 0.0075 m3 |
0.778 feet3 or 0.022 m3 |
| 30 |
0.33 feet3 or 0.009 m3 |
0.93 feet3 or 0.027 m3 |
| 50 |
0.55 feet3 or 0.015 m3 |
1.55 feet3 or 0.043 m3 |
| 100 |
1.10 feet3 or 0.03 m3 |
3.10 feet3 or 0.087 m3 |
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What are your normal business hours?
Our hours of operation are 7:30 am to 4:00 pm Eastern Standard Time.
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How can I get assistance for registering?
Please contact Ankush Randhawa or Steve Jamieson for assistance during our regular business hours (7:30 am to 4:00 pm Eastern Standard Time).
Ankush Randhawa arandhawa@precisionbiologic.com
Steve Jamieson sjamieson@precisionbiologic.com
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Do you have any jobs available?
We don't post job openings on our website. If you are interested in a career with Precision BioLogic, please send an inquiry to careers@precisionbiologic.com.
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Are you associated with all of the organizations linked from your site?
No. However, we have received permission from the organizations listed on our Links section to set up links to their website.
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The quality and convenience of the Precision BioLogic solution is just a phone call away.
1.800.267.2796
