21 CFR 862.1170 - Chloride test system.

Code of Federal Regulations - Title 21: Food and Drugs

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H: MEDICAL DEVICES

PART 862: CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Subpart B: Clinical Chemistry Test Systems

862.1170 - Chloride test system.

(a) Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

(b) Classification. Class II.

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