Enzymatic (Glutathione Reductase), Glutathione
This device is an enzymatic reagent system using glutathione reductase to measure glutathione in patient specimens by monitoring reduction reactions, used in evaluating oxidative stress status and red blood cell metabolic capacity relevant to hemolytic conditions and nutritional assessment. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket submission. The product code is JLO, regulated under 21 CFR 862.1365, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JLO
- Device Class
- FDA class 1
- Regulation Number
- 862.1365
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.