21 CFR 864.7440 — System, Analysis, Electrophoretic Hemoglobin

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7440

Identification

An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JBDSystem, Analysis, Electrophoretic Hemoglobin2263rd Party
Innolitics

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