Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.)
Clinical Chemistry · 21 CFR 862.1115
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
132 firms currently registered for this product code
Teco Diagnostics
ANAHEIM, CA, US
Btnx Inc.
Pickering Ontario, CA
Healgen Scientific Llc
Houston, TX, US
Arkray, Inc.
Kamigyo-ku Kyoto, JP
Siemens Healthcare Diagnostics Inc
East Walpole, MA, US
Changchun Lyz Technology Co.,ltd
Changchun City Jilin, CN
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Chong Qing Teco Huayi Pharm. Co.
Shapingba Dist., Chongqing, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Nova Biomedical Corporation
Billerica, MA, US
Stanbio Laboratory
Boerne, TX, US
Changchun Wancheng Bio-electron Co., Ltd.
Changchun Jilin, CN
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Acon Laboratories, Inc.
SAN DIEGO, CA, US
Nova Biomedical Corporation
WALTHAM, MA, US
Yd Diagnostics
Yongin-si Gyeonggi, KR
Scientific Supplies & Technology, Inc.
Doral, FL, US
Toptolife Diagnostics Llc
Wilmington, DE, US
Platinum Focus Group Ltd.
London London, City of, GB
510(k) clearances
5 clearances for this product code
- Teco DiagnosticsApr 24, 1995
K943436 · URINE REAGENT STRIPS-8 PARAMETERS
- Genesis Labs, Inc.Aug 8, 1994
K943008 · BIOSCAN REAGENT STRIPS
- Wako Chemicals USA, Inc.Sep 22, 1987
K873553 · WAKO(TM) PRETEST 8A
- Amatech International, Inc.Dec 4, 1986
K862806 · URINE DIAGNOSTIC REAGENT STRIPS
- Syn-Kit, Inc.Jan 11, 1984
K833521 · REAGENT TESTS STRIP COMBINATIONS