21 CFR 862.1113 — Bilirubin (Total And Unbound) In The Neonate Test System
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1113
Identification
A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Classification Rationale
Class I.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 1 | 17 | 3rd Party |
