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cobas® Babesia - Diagnostics
- https://diagnostics.roche.com/global/en/products/params/cobasbabesia.html
- The Roche Whole Blood Collection Tube is a direct draw whole blood collection tube. It is intended for the collection, transport, storage and lysis of whole blood and subsequent …
FDA approves cobas Babesia - Roche’s first whole blood assay …
- https://diagnostics.roche.com/global/en/news-listing/2019/fda-approves-cobas-babesia.html
- This is Roche’s first commercially available whole blood test to screen donations and follows May 2019 FDA updated industry guidance recommending …
cobas® Babesia - Diagnostics
- https://diagnostics.roche.com/nl/en/products/params/cobasbabesia.html
- The Roche Whole Blood Collection Tube is a direct draw whole blood collection tube. It is intended for the collection, transport, storage and lysis of whole blood and subsequent …
Roche to initiate testing for Babesia parasite at U.S.
- https://www.prnewswire.com/news-releases/roche-to-initiate-testing-for-babesia-parasite-at-us-blood-centers-under-fda-investigational-new-drug-application-protocol-300529600.html
- Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of …
FDA approves cobas Babesia, Roche’s first whole blood …
- https://www.globenewswire.com/news-release/2019/09/20/1918386/0/en/FDA-approves-cobas-Babesia-Roche-s-first-whole-blood-test-for-donor-screening.html
- Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central …
Roche secures US approval for test to detect Babesia infection
- https://www.medicaldevice-network.com/news/roche-fda-babesia-test/
- Roche has secured US regulatory approval for cobas Babesia, a qualitative in-vitro nucleic acid screening test for individual blood donations. The US Food and Drug Administration …
Roche Gains FDA Clearance for Cobas Babesia Blood Test
- https://www.genomeweb.com/regulatory-news-fda-approvals/roche-gains-fda-clearance-cobas-babesia-blood-test
- Babesia parasites can't be detected in traditional plasma or serum samples, so Roche's test uses the whole-blood collection tube to simplify sample preparation. The …
Licensed Biological Products with Supporting Documents …
- https://www.fda.gov/vaccines-blood-biologics/licensed-biological-products-supporting-documents
- The list is arranged alphabetically by the proper name of the product (s). Information is provided for original product approvals, new indications, and the current …
Procleix Babesia Assay | FDA
- https://www.fda.gov/vaccines-blood-biologics/procleix-babesia-assay
- The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, …
Roche | Biochemical Pathways
- https://www.roche.com/about/philanthropy/science-education/biochemical-pathways/
- Roche Biochemical Pathways. Explore the pathways. Mapping the paths of life. Biochemical Pathways provide an overview of the chemical reactions of cells in various …
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