Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
This device is a colorimetric reagent system using azo-dyes to detect bilirubin and its conjugates qualitatively in urine on a non-quantitative basis, used as part of urinalysis to screen for liver disease, bile duct obstruction, or hemolytic conditions. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The product code is JJB, regulated under 21 CFR 862.1115, and belongs to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JJB
- Device Class
- FDA class 1
- Regulation Number
- 862.1115
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K943436 | URINE REAGENT STRIPS-8 PARAMETERS | Apr 24, 1995 | Substantially Equivalent | Teco Diagnostics |
| K943008 | BIOSCAN REAGENT STRIPS | Aug 08, 1994 | Substantially Equivalent | Genesis Labs, Inc. |
| K873553 | WAKO(TM) PRETEST 8A | Sep 22, 1987 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K862806 | URINE DIAGNOSTIC REAGENT STRIPS | Dec 04, 1986 | Substantially Equivalent | Amatech International, Inc. |
| K833521 | REAGENT TESTS STRIP COMBINATIONS | Jan 11, 1984 | Substantially Equivalent | Syn-Kit, Inc. |
FEI Numbers
This FDA classification entry is associated with 65 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 65 registration numbers. Click on an entry to view related FDA registrations.