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Bilirubin (Total And Unbound) In The Neonate Test System

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
862.1113
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1113 Bilirubin (total and unbound) in the neonate test system

§ 862.1113 Bilirubin (total and unbound) in the neonate test system.

(a) 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).

(b) Classification. Class I.

[54 FR 30206, July 19, 1989]

Bilirubin (Total And Unbound) In The Neonate Test System

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
862.1113
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1113 Bilirubin (total and unbound) in the neonate test system

§ 862.1113 Bilirubin (total and unbound) in the neonate test system.

(a) 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).

(b) Classification. Class I.

[54 FR 30206, July 19, 1989]