CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART I—Hematology Reagents (§864.8100 to §864.8950) > 864.8950—Russell viper venom reagent.

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).

Code of Federal Regulations

[45 FR 60637, Sept. 12, 1980]