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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: 21CFR866.5260]
See Related Information on Complement C3binactivator immunological test system. 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 F--Immunological Test Systems

Sec. 866.5260 Complement C3binactivator immunological test system.

(a)Identification. A complement C3binactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3binactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3binactivator aids in the diagnosis of inherited antibody dysfunction.

(b)Classification. Class II (performance standards).

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