21 CFR 864.8950 - Russell viper venom reagent.

Code of Federal Regulations - Title 21: Food and Drugs

Updated to: April 01, 2011

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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 864: HEMATOLOGY AND PATHOLOGY DEVICES

Subpart I: Hematology Reagents

864.8950 - Russell viper venom reagent.

(a) Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.

(b) Classification. Class I (general controls).

[45 FR 60637, Sept. 12, 1980]