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Updated: 3 hours 10 min ago

Alphanate

Thu, 02/15/2018 - 06:04
Categories: FDA News

Advate

Thu, 02/15/2018 - 05:56
Categories: FDA News

Auszyme Monoclonal

Wed, 02/14/2018 - 11:45
Product approval information is indicated for use to include cadaveric serum specimen testing.
Categories: FDA News

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry

Wed, 02/14/2018 - 08:45
This is the Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.
Categories: FDA News

NovoSevenRT

Wed, 02/14/2018 - 07:32
Categories: FDA News

NovoSeven

Wed, 02/14/2018 - 07:26
Categories: FDA News

Anti-B (Murine Monoclonal)

Mon, 02/12/2018 - 09:50
Categories: FDA News

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)

Fri, 02/02/2018 - 15:33
Contains list of Establishments Granted Approval for a Variance to 21CFR640.3 (d) and 21CFR640.3 (f) that contains names of Facility, addresses, Licensed, Registered-Only, 640.3(d) Approvals, 640.3(f) Approvals and Approval Date.
Categories: FDA News

Biologics Guidances

Fri, 02/02/2018 - 12:40
This page displays links to Biologics Guidance documents.
Categories: FDA News

Abbott Prism Chagas

Fri, 02/02/2018 - 09:21
The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens.
Categories: FDA News

ORTHO T. cruzi ELISA Test System

Fri, 02/02/2018 - 08:23
Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of whole blood, blood components or source plasma, and other living donors. It is also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating
Categories: FDA News