Nitroprusside Reaction (Qualitative, Urine), Cystine
This device is a clinical chemistry test system using the nitroprusside reaction to qualitatively detect cystine in urine specimens, used as a screening tool for cystinuria, a hereditary disorder characterized by defective renal reabsorption of cystine and other dibasic amino acids leading to kidney stone formation. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket notification. The product code is JLC, regulated under 21 CFR 862.1240, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JLC
- Device Class
- FDA class 1
- Regulation Number
- 862.1240
- 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.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.