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Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1785
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1785 Urinary urobilinogen (nonquantitative) test system

§ 862.1785 Urinary urobilinogen (nonquantitative) test system.

(a) Identification. A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

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

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]

Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1785
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1785 Urinary urobilinogen (nonquantitative) test system

§ 862.1785 Urinary urobilinogen (nonquantitative) test system.

(a) Identification. A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

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

[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]