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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR866.3050]
See Related Information on Beta-glucan serological assays. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES

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 866.1(e) for the availability of this guidance document.

[69 FR 56936, Sept. 23, 2004]

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