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Radioimmunoassay, Thyroxine-Binding Globulin

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
862.1685
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1685 Thyroxine-binding globulin test system

§ 862.1685 Thyroxine-binding globulin test system.

(a) Identification. A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)-binding globulin (TBG), a plasma protein which binds thyroxine, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]

Radioimmunoassay, Thyroxine-Binding Globulin

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
862.1685
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1685 Thyroxine-binding globulin test system

§ 862.1685 Thyroxine-binding globulin test system.

(a) Identification. A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)-binding globulin (TBG), a plasma protein which binds thyroxine, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019]