Diazo, Alt/Sgpt
The Diazo, ALT/SGPT test system (product code CJJ) is an in-vitro diagnostic device used in clinical chemistry to measure alanine aminotransferase (ALT/SGPT) enzyme activity in serum using a diazo colorimetric reaction, supporting the diagnosis of liver disease and hepatocellular injury. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1030 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CJJ
- Device Class
- FDA class 1
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.