Blood, Occult, Colorimetric, In Urine
Hematology · 21 CFR 864.6550
Recent MDR events
18 adverse event reports on file
- MULTISTIX 10 SG URINE DIP STICKSSep 4, 2025MalfunctionSiemens Healthcare Diagnostics Inc.22962609
- MEDLINE URINALYSIS REAGENT STRIPSJun 5, 2025MalfunctionAcon Laboratories, Inc.2531491-2025-00122
- DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)Jun 28, 2024InjuryLife2oMW5156830
- COMBUR 10 TESTJul 27, 2015MalfunctionRoche Diagnostics1823260-2015-03866
- URISYS 1100Jun 6, 2014MalfunctionRoche Diagnostics1823260-2014-04136
- CLINITEK 500 ANALYZERMay 7, 2014MalfunctionSiemens Healthcare Diagnostics1217157-2014-00066
- MULTISTIX 10SG STRIPSFeb 14, 2014OtherSiemens Healthcare Diagnostics Inc.1217157-2014-00020
- MULTISTIX 10SG STRIPSJan 13, 2014OtherSiemens Healthcare Diagnostics Inc1217157-2013-00260
- MULTISTIX 10SG STRIPSNov 22, 2013OtherSiemens Healthcare Diagnostics Inc.1217157-2013-00222
- MULTISTIX 10SG STRIPSJul 19, 2013OtherSiemens Healthcare Diagnostics Inc.1217157-2013-00131
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
104 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
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Chong Qing Teco Huayi Pharm. Co.
Shapingba Dist., Chongqing, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Stanbio Laboratory
Boerne, TX, US
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Acon Laboratories, Inc.
SAN DIEGO, CA, 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
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Fisher Diagnostics
MIDDLETOWN, VA, US
Urit Medical Electronic Co., Ltd.
Guilin Guangxi, CN
510(k) clearances
11 clearances for this product code
- Urit Medical Electronic Co., Ltd.Apr 26, 2024
K232317 · UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
- Healgen Scientific,, LLCApr 17, 2012
K111999 · HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
- ACON Laboratories, Inc.Jan 18, 2012
K111221 · MISSION U500 URINE ANALYZER
- Urit Medical Electronic Co., Ltd.Sep 11, 2009
K082811 · URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
- Wiener Laboratorios SaicSep 2, 2009
K083724 · WIENER LAB. URINE STRIP 10 AND 11
- Dirui Industrial Co., Ltd.Aug 26, 2004
K040703 · URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
- Teco DiagnosticsMar 6, 2003
K023297 · URS-1B (BLOOD TEST)
- Symcon Intl., Inc.Jul 21, 1992
K921495 · DIA STRIPS SYSTEM, MODIFIED