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[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
[CITE: 21CFR862.1495]
 See Related Information on 862.1495 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. 862.1495 Magnesium test system.

(a)Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

(b)Classification. Class I.

Database Updated April 1, 2008

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