Kit, Screening, Urine
Microbiology · 21 CFR 866.2660
Recent MDR events
69 adverse event reports on file
- CHROMID CPS ELITE 100 PL TRANS - 416172Dec 2, 2025MalfunctionBiomérieux Sa3009307598-2025-00003
- CHROMID CPS ELITE 100 PL TRANS®Nov 20, 2025MalfunctionBiomérieux, Sa3009307598-2025-00002
- CHROMID® CPS® ELITE AGARJul 3, 2025Malfunction3009307598-2025-00001
- CHROMID CPS ELITE 20 PLT TRANS - 418284Aug 14, 2023MalfunctionBiomérieux Sa3009307598-2023-00002
- CHROMID® CPS® ELITEMar 13, 2023MalfunctionBiomérieux, Sa3009307598-2023-00001
- CHROMID® CPS® ELITEAug 18, 2022MalfunctionBiomérieux, Sa3009307598-2022-00004
- CHROMID® CPS® ELITE OPAQUEAug 18, 2022MalfunctionBiomérieux, Sa3009307598-2022-00005
- CHROMID® CPS® ELITE AGARApr 6, 2022Malfunction3009307598-2022-00001
- CHROMID CPS ELITE 100 PL TRANSMar 21, 2022MalfunctionBiomerieux S.a.9615755-2022-00010
- CHROMID CPS ELITE 100 PL TRANSMar 21, 2022MalfunctionBiomerieux S.a.9615755-2022-00011
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
30 firms currently registered for this product code
Teco Diagnostics
ANAHEIM, CA, US
Jilin Test Bio-electron Co.,ltd
Changchun Jilin, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Pt Nsp Technology Batam
Batu Ampar Riau, ID
Weihai Kangzhou Biotechnology Engineering Co., Ltd.
Weihai Shandong, CN
Sterigenics U.s., Llc
Tustin, CA, US
Andwin Scientific
Simi Valley, CA, US
Weihai Kangzheng Medical Equipments Technology Co.,ltd
weihai Shandong, CN
Aero-med Llc
East Hartford, CT, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Mast Group Ltd.
BOOTLE, MERSEYSIDE Liverpool, GB
Changchun Merydi Bio-tech Co., Ltd.
changchun Jilin, CN
Nsp Tech Pte Ltd
Singapore Central Singapore, SG
Precision Medical Devices Inc
New Brunswick, NJ, US
Tri-tech Forensics, Inc.
Leland, NC, US
Onlycare Inc
Denver, CO, US
Eng Scientific Llc
New Brunswick, NJ, US
Changchun Lyz Technology Co.,ltd
Changchun City Jilin, CN
Medical Chemical Corporation
TORRANCE, CA, US
Biomerieux France
CRAPONNE Rhone, FR
Savyon Diagnostics Ltd.
ASHDOD Southern, IL
Jant Pharmacal Corp.
ENCINO, CA, US
Changchun Wancheng Bio-electron Co., Ltd.
Changchun Jilin, CN
Dynamic Diagnostics Incorporated
Plymouth, MI, US
510(k) clearances
44 clearances for this product code
- OsmetechNov 30, 2001
K011043 · OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
- Diatech Diagnostics,Inc.Oct 7, 1998
K981084 · URISCREEN
- Combact Diagnostic Systems , Ltd.Feb 23, 1998
K972676 · URINE SCREENING DEVICE
- Tri-Tech, Inc.Jun 20, 1995
K952246 · TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
- Izon Business Products, Inc.Apr 14, 1995
K950257 · MULTIPLE (IZON DBS & URINE COLLECTION KIT)
- Izon Business Products, Inc.Mar 21, 1995
K950221 · MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
- Izon Business Products, Inc.Mar 21, 1995
K950246 · MULTIPLE (IZON URINE COLLECTION KIT)
- Clinical Convenience Products, Inc.Sep 9, 1994
K934759 · CULTURIA MACCONKEY-MUG