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Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1187
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1187 Conjugated sulfolithocholic acid (SLCG) test system

§ 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.

(a) Identification. A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

(b) Classification. Class II.

Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1187
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1187 Conjugated sulfolithocholic acid (SLCG) test system

§ 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.

(a) Identification. A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

(b) Classification. Class II.