IVD | GenomeWeb

IVD

Tulip Diagnostics Private provides in vitro diagnostic reagents, kits, and instruments to labs, and government and private healthcare facilities in India.

The company said the cartridge now covers 102 diagnostic targets including 85 pathogens and 17 treatment resistance markers.

The diagnostics provider said it has paid $250,000 for assets comprised of promissory notes, Series A and Series B stock, and intellectual property.

The finalized guidance sets requirements for label implementation, electronic labeling, symbols on small containers, and blood glucose monitoring systems.

The agreement calls for HTG to develop several in vitro diagnostics on Thermo Fisher's next-generation sequencing-based Ion PGM Dx system.

NEW YORK (GenomeWeb News) – The Food and Drug Administration has released a guidance document that lays out and clarifies the rules for how in vitro diagnostic products for research use only (RUO) and investigational use only (IUO) may be used, labeled, or marketed.

After appointing a new CEO this summer, SQI Diagnostics is continuing its focus on services to pharmaceutical partners in providing custom multiplex immunogenicity panels, with its pipeline of in vitro diagnostics assays as a second priority, the company said this week.

Luminex hopes to see two new screening assays cleared by the US Food and Drug Administration next year that together address a market opportunity of about $200 million.

Members of a US House of Representatives subcommittee have called on the US Food and Drug Administration to respond to "significant concern" regarding the agency's draft guidance document on research-use-only and investigational-use-only diagnostic products.

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