Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan (PDF version)
Detailed guidance document from FDA and regulatory agencies.
Document Details
Special Controls Document
September 23, 2004
December 1, 2018
4fa93abb-1a1e-4d2b-ac9e-eed807e3dfbf
Related Documents
Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff
Special Controls DocumentSeptember 22, 2005Center for Devices and Radiological Health
Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System (PDF version)
Special Controls DocumentMay 11, 2004Center for Devices and Radiological Health
Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff
Special Controls DocumentJune 2, 2003Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.