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System, Test, Vitamin D

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1825
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1825 Vitamin D test system

§ 862.1825 Vitamin D test system.

(a) Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

(b) Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:

(1) Labeling in conformance with 21 CFR 809.10 and

(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

[63 FR 40366, July 29, 1998]

System, Test, Vitamin D

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1825
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1825 Vitamin D test system

§ 862.1825 Vitamin D test system.

(a) Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

(b) Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:

(1) Labeling in conformance with 21 CFR 809.10 and

(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

[63 FR 40366, July 29, 1998]