Frequently Asked Questions - General Questions

What are some of the advantages of using SurModics Stabilization Products?

1. They increase the shelf life of your diagnostic kit;

2. They decrease the variability often associated with shipping and storage conditions;

3. They reduce error by eliminating the conjugate dilution step;

4. They increase convenience as they are ready-to-use;

5. The preservatives present in some of the products do not contain mercury or azide, eliminating the use and disposal restrictions associated with these types of preservatives;

6. They have routinely shown unsurpassed stability and efficacy compared to standard reagents and competitor products currently on the market;

7. Using SurModics Stabilization Products in place of your own in-house reagents can reduce your costs and save you time.

What ingredients do the stabilizers contain?

The product formulations are trade secrets; therefore, we cannot disclose any of the proprietary ingredients. Please refer to the generic description of each product.

How can I get a product approved without knowing what’s in it?

--All of our products are manufactured according to QSR guidelines, under ISO 9001 and 13485;

--Certificates of Conformance are provided to confirm that the products meet all specifications prior to being released for sale;

--Material Safety Data Sheets (MSDS) are available for all of the products;

--All of the products are proven, critical components of several commercially available diagnostic devices.

Are there any test kits approved through the FDA that incorporate SurModics stabilizers as components?

Yes!

Will any of the Stabilization Products interfere with my assays?

Generally no, but always test first to ensure compatibility with your assay. If StabilZyme HRP Conjugate Stabilizer shows interference in competitive assays, we recommend trying StabilZyme SELECT or StabilZyme NOBLE (BSA-Free) Stabilizers.

Is it okay that samples are shipped at room temperature, even though storage recommendations state "Store refrigerated or at room temperature"?

None of our stabilization products require refrigeration during transit, and are shipped under ambient conditions. The shelf life studies at room temperature support this. In addition, the products have historically been shipped under these conditions with no adverse effects in product shelf-life, quality, or performance.

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