21 CFR 864.8950 — Reagent, Russel Viper Venom

Hematology (HE) · Part 864 Subpart I—Hematology Reagents · § 864.8950

Identification

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

Classification Rationale

Class I (general controls).

Product Codes

Product CodeDevice NameClassDevicesAttributes
GIRReagent, Russel Viper Venom1163rd Party
Innolitics

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