Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1115](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1115) → JJB — Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

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

_Clinical Chemistry · 21 CFR 862.1115 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB

## Overview

- **Product Code:** JJB
- **Device Name:** Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- **Regulation:** [21 CFR 862.1115](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1115)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K943436](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB/K943436.md) | URINE REAGENT STRIPS-8 PARAMETERS | Teco Diagnostics | Apr 24, 1995 | SESE |
| [K943008](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB/K943008.md) | BIOSCAN REAGENT STRIPS | Genesis Labs, Inc. | Aug 8, 1994 | SESE |
| [K873553](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB/K873553.md) | WAKO(TM) PRETEST 8A | Wako Chemicals USA, Inc. | Sep 22, 1987 | SESE |
| [K862806](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB/K862806.md) | URINE DIAGNOSTIC REAGENT STRIPS | Amatech International, Inc. | Dec 4, 1986 | SESE |
| [K833521](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB/K833521.md) | REAGENT TESTS STRIP COMBINATIONS | Syn-Kit, Inc. | Jan 11, 1984 | SESE |

## Top Applicants

- Amatech International, Inc. — 1 clearance
- Genesis Labs, Inc. — 1 clearance
- Syn-Kit, Inc. — 1 clearance
- Teco Diagnostics — 1 clearance
- Wako Chemicals USA, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJB)

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