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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: 21CFR862.1820]
See Related Information on Xylose 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 862 -- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Subpart B--Clinical Chemistry Test Systems

Sec. 862.1820 Xylose test system.

(a)Identification. A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]

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