Bluechiip Limited (BCT.AX) Secures FDA Registration and CE IVD Certification
Melbourne, Australia, Nov 30, 2021 - (ABN Newswire) - Bluechiip Limited (ASX:BCT) (HAM:1BL), a leader in the development of advanced sample management solutions for harsh environments, today announced the recent registration of Bluechiip's own branded cryovials with the United States FDA (USA) and receipt of the European CE IVD certification.
These important US and EU certifications enable the company to directly sell into these key target margets.
The company has now globaly launched its Bluechiip-Enabled sample management solutions product line, including Sample Storage consumables, Readers, and Stream(TM) Sample Management Software.
The company plans to market and sell the Bluechiip-Enabled product line directly into North America and Australia/New Zealand and through distribution partners across European and Asia Pacific markets.
Andrew McLellan, Bluechiip Managing Director, described the announcement as very exciting for Bluechiip.
'Certification is important; over the last 18 months we have worked on and achieved certification of our ISO9001 quality management system under which we have validated all our products. FDA registration and CE IVD certification means we can sell directly into the USA, as well as into Europe and the Asia/Pacific region.
The product launch places Bluechiip in a position to directly market a full range of Bluechiip branded products to end customers. We are now talking directly to end customers in biobanking, research, clinical trials, and pharmaceutical companies across the life sciences space. Importantly, we can now deliver customized readers, software and sample storage consumables.
We have also rolled out a marketing campaign, including updating our website. Bluechiip now has a full product catalogue, including a range of accessories, readers and consumables, backed up by appropriate software. We have de-risked the business and are in control of our own future.
Most importantly for our end customers we are focused on redefining quality, driving productivity and at the end of the day providing confidence in every sample and we have already received orders, and made installations, during the past two months in Europe and Australia and look forward to expanding our customer base especially in North America.'
Mr McLellan said Bluechiip was focused on its direct to market products while continuing to work with the company's partners, including FujiFilm Industries Irvine Scientific (FISI), as well as other potential partners to expand Bluechiip's technology application across multiple markets.
About Bluechiip Limited:
Bluechiip Limited (ASX:BCT) understands that every sample - stem cells, blood, eggs, sperm and other biospecimens - is critical, so our objective is to manage each one with optimal quality in the most efficient way. Bluechiip's advanced management solution is the only one that provides sample temperature with ID in cryogenic environments to. Most importantly, this delivers confidence in every sample.
Bluechiip's unique patented technology is a MEMS-based wireless tracking solution that contains no electronics. It represents a generational change from current tracking methods such as labels (hand-written and pre-printed), barcodes (linear and 2D), and Radio Frequency Identification. Bluechiip tags are either embedded or manufactured into storage products such as vials or bags. Each product can be easily identified, and critical information such as sample temperature, is detected by readers and stored in the Bluechiip software. In addition to functioning in extreme temperatures, the Bluechiip(R) Advanced Sample management solution can survive autoclaving, gamma irradiation sterilization, humidification, centrifuging, cryogenic storage and frosting.
Bluechiip's technology has applications in healthcare, including in cryogenic storage facilities (biobanks and biorepositories), pathology, clinical trials and forensics. Other key markets include cold-chain logistics/supply chain, security/defence, industrial/manufacturing and aerospace/aviation.
Bluechiip: Delivering confidence in every sample.
Managing Director - CEO
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