FAQBiofyl Scientific Research

Get answers to our most frequently asked questions here, and feel free to contact us if you don't see your question on this page.
What is a CRO?

A contract research organization (CRO) is an independent research company that is contracted by pharmaceutical, medical device and other biotech companies to perform research services. BSRLabs conducts testing primarily for Research & Development, Marketing and Regulatory purposes. BSR also works with collaborators in support of academic investigator-led studies.

What laboratory services does BSR provide?

BSR provides the following services:

  • Medical Device Testing
  • Bioassay Development and Validation
  • Stem Cell Analysis
  • Contract Cell Culture
  • Flow Cytometry
What is included in a bioassay kit?

A bioassay kit includes 2 sterile sample vials, a biohazard bag, shipping materials and a return shipping label. The cost for the bioassay kit also covers the cost of testing.

Does BSR provide support for 510k submissions?

BSR has specialized expertise in the evaluation of Class II devices, used in the preparation of PRP and stem cell concentrates, for 510k equivalence testing. BSR has conducted testing for a substantial number of concentrating devices that are currently commercially available.

How long does a 510k study take to complete?

510k equivalence studies typically take 4 – 8 weeks depending on the study sample size.

Is comparison testing for other purposes besides regulatory?

Yes. BSR routinely performs small and large-scale studies for head-to-head comparisons of concentrating devices and PRP products. Clients, including clinicians, request testing for internal validation purposes, as well as for published marketing studies.

What is the cost of testing?

The cost of our most performed bioassays are listed on the website. (insert link) for customized testing and studies, please contact us for pricing.

What days do you accept biospecimen sample shipments?

We accept sample collections & shipments Monday through Thursday.  We ask that sample collections and shipments not be done on Fridays because the lab is closed on weekends.  That means samples and shipments done on Friday run the risk of sitting in a delivery warehouse until the following Monday or Tuesday.