[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.3050]

[Page 261]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866_IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                     Subpart D_Serological Reagents
 
Sec. 866.3050  Beta-glucan serological assays.

    (a) Identification. Beta-glucan serological assays are devices that 
consist of antigens or proteases used in serological assays. The device 
is intended for use for the presumptive diagnosis of fungal infection. 
The assay is indicated for use in patients with symptoms of, or medical 
conditions predisposing the patient to invasive fungal infection. The 
device can be used as an aid in the diagnosis of deep seated mycoses and 
fungemias.
    (b) Classification. Class II (special controls). The special control 
is FDA's guidance document entitled ``Class II Special Controls Guidance 
Document: Serological Assays for the Detection of Beta-Glucan.'' See 
Sec. 866.1(e) for the availability of this guidance document.

[69 FR 56936, Sept. 23, 2004]