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FDA product code JJB

Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

Clinical Chemistry·Class 1·21 CFR 862.1115
US regulatory classifications
US Product Code (FDA)
JJB
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 862.1115
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Search keywords

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01Bilirubin test02Urine bilirubin03Azo dye04Colorimetric test05Urinalysis06Diagnostic reagent07Urine test strip08Lab dye09Conjugated bilirubin10Diagnostic chemistry
About this record

Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.