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Lab21 Announces its First 510(k) Approval and Further Expansion of new Products

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Lab21 Limited announce new developments in its Products Division. The new developments include its first FDA approval for the US market, the introduction of a new infectious disease screening diagnostic assay and further expansion of sales into new territories.

Lab21 has expanded the availability of its blood bank screening range of diagnostic assays, having recently secured 510(k) clearance in the US for its Syphilis Treponema Pallidum Haemagglutination (TPHA) Assay, which is formatted to run on the Beckman Coulter PK7200 platform. This is the first of a number of FDA approvals that will be sought as it expands its distribution presence in the world’s largest diagnostic market.

The company also announces today that it has just launched a new CE marked cytomegalovirus Haemagglutination (CMV HA) assay, which has been formatted to run on both the Beckman Coulter PK7200 and 7300 platforms where  the liquid stable reagents provide a significant ease of use advantage.

Lab21 has also recently expanded its global sales, into new territories in the Asia-Pacific region through the renewal and extension of a partnership with Alere.

Hayden Jeffreys, Divisional Director, Products at Lab21 commented: “Lab21 continues to grow, having achieved a number of important milestones this year. We are pleased to see a number of key centres in Europe performing validation studies for CMV HA prior to adoption as a routine service further strengthening our position as reagent provider in this market.  Coupled with the expansion into new territories and products this means Lab21 is in a strong position for future growth.”

Graham Mullis, CEO of Lab21, added: “These achievements underline our commitment to supporting blood banks worldwide by providing high quality reagents. Lab21 is committed to global expansion, and we are very pleased to continue to be able to expand our operations in the US and Australia.”