FDA.reportPublic FDA data

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick (strip) method. This test is commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins].
GUDID devices
62
Last updated
2022-10-11 19:13:25

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08806141303077One+Step Uric AcidDFI CO.,LTD31H0P2022-10-03
80888277677790MedlineMEDLINE INDUSTRIES, INC.MPHUAMAC2022-08-04
80884389181972MedlineMEDLINE INDUSTRIES, INC.MPHUAURO72022-04-13
00023513487441DG HealthREESE PHARMACEUTICAL COMPANYUTES2020-06-01
04015630004652Urisys 2400 CassetteRoche Diagnostics GmbH30125570612016-09-20
08806125680019URiSCAN 10 SGL stripYD Diagnostics CORP.U3912016-08-05
08806125680033URiSCAN 2 GP stripYD Diagnostics CORP.U2012016-09-01
08806125680064URiSCAN 6 L stripYD Diagnostics CORP.U2512016-09-01
08806125680217URiSCAN 10 SGL stripYD Diagnostics CORP.U7742016-12-21
08806125680224URiSCAN 2 ACR stripYD Diagnostics CORP.U6432016-08-05
08806125680231URiSCAN 10 ACR stripYD Diagnostics CORP.U6212016-08-05
08806125680279UCARE 11 StickYD Diagnostics CORP.P4112017-07-28
08806125680286UCARE 11 StickYD Diagnostics CORP.P4122017-07-28
08806141300755CYBOW 11DFI CO.,LTD0A942016-10-06
08806141301479QTEST™ 11DFI CO.,LTD09942018-12-21
10612479183466McKessonMCKESSON MEDICAL-SURGICAL INC.121-2GP2016-12-09
10612479183497McKessonMCKESSON MEDICAL-SURGICAL INC.121-4LN2016-12-09
10612479183527McKessonMCKESSON MEDICAL-SURGICAL INC.121-10SG2016-12-09
10612479197463McKessonMCKESSON MEDICAL-SURGICAL INC.121-6OB2016-12-09
10612479197494McKessonMCKESSON MEDICAL-SURGICAL INC.121-MAC2016-12-09
10673486000016TECO DIAGNOSTICSTECO DIAGNOSTICSURS-10-1002016-09-27
10673486000023TECO DIAGNOSTICSTECO DIAGNOSTICSURS-10 100 Teco (RUSSIAN)2016-09-27
10673486000030TECO DIAGNOSTICSTECO DIAGNOSTICS URS-10-100 SPANISH2016-09-27
10673486000047TECO DIAGNOSTICSTECO DIAGNOSTICSURS-10-100 GENERIC2016-09-27
10673486000054TECO DIAGNOSTICSTECO DIAGNOSTICSURS-10-100 BOTTLE2016-09-27
10673486000061TECO DIAGNOSTICSTECO DIAGNOSTICSURS-10-100 USA2016-09-27
10673486000078TECO DIAGNOSTICSTECO DIAGNOSTICSURS-10-100 LABELED BOTTLE2016-09-27
10673486000214TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2K-1002016-10-04
10673486000221TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2K-100 BOTTLE2016-10-04
10673486000238TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2K-100 GENERIC2016-10-04
10673486000245TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2M-252017-01-05
10673486000252TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2M-25 BOTTLE2017-01-05
10673486000269TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2P-1002017-01-05
10673486000276TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2P-100 BOTTLE2017-01-05
10673486000283TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2P-100 GENERIC2017-01-05
10673486000290TECO DIAGNOSTICSTECO DIAGNOSTICSURS-3-100 2016-10-04
10673486000306TECO DIAGNOSTICSTECO DIAGNOSTICSURS-3-100 BOTTLE2016-10-04
10673486000313TECO DIAGNOSTICSTECO DIAGNOSTICSURS-3-100 GENERIC2016-10-04
10673486000320TECO DIAGNOSTICSTECO DIAGNOSTICSURS-4S-1002016-10-03
10673486000337TECO DIAGNOSTICSTECO DIAGNOSTICSURS-4S-100 BOTTLE2017-01-05
10673486000344TECO DIAGNOSTICSTECO DIAGNOSTICSURS-4S-100 GENERIC2017-01-05
10673486000351TECO DIAGNOSTICSTECO DIAGNOSTICSURS-5K-1002017-01-05
10673486000368TECO DIAGNOSTICSTECO DIAGNOSTICSURS-5K-100 BOTTLE2017-01-05
10673486000375TECO DIAGNOSTICSTECO DIAGNOSTICSURS-5K-100 GENERIC2017-01-05
10673486000405TECO DIAGNOSTICSTECO DIAGNOSTICSURS-9-100 GENERIC2017-01-05
10673486000429TECO DIAGNOSTICSTECO DIAGNOSTICSURS-11-1002018-01-19
10673486000443TECO DIAGNOSTICSTECO DIAGNOSTICSURS-11-502018-01-19
10673486000450TECO DIAGNOSTICSTECO DIAGNOSTICSURS-OBGYN-1002018-01-08
10673486000535TECO DIAGNOSTICSTECO DIAGNOSTICSURS-6L-1002018-01-04
10673486000559TECO DIAGNOSTICSTECO DIAGNOSTICSURS-3-100 GENERIC LABELED BOTTLE2018-02-12
10673486000566TECO DIAGNOSTICSTECO DIAGNOSTICSURS-5K-502018-02-12
10673486000573TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2M-25 GENERIC2018-02-12
10673486000580TECO DIAGNOSTICSTECO DIAGNOSTICSURS-3-50-01 MUSTAFA2018-02-21
10673486000603TECO DIAGNOSTICSTECO DIAGNOSTICSURS-3-50 FINISHED KIT 2018-02-28
10673486000610TECO DIAGNOSTICSTECO DIAGNOSTICSURS-6-100 TECO FINISHED KIT2018-03-27
10673486000627TECO DIAGNOSTICSTECO DIAGNOSTICSURS-4B-1002018-10-09
10673486000634TECO DIAGNOSTICSTECO DIAGNOSTICSURS-4B-100-1082018-10-09
10673486000641TECO DIAGNOSTICSTECO DIAGNOSTICSURS-2K-100GL BOTTLE WITH LABEL2018-11-01
20722355002198Detector UA 5IMMUNOSTICS COMPANY, INCIDU-5OB2016-09-25
20722355002204Detector UA 10IMMUNOSTICS COMPANY, INCIDU-102016-09-26
20722355002921Detector UA 10SGIMMUNOSTICS COMPANY, INCIDU-10SG2018-11-20
10837461002536vChem®IRIS INTERNATIONAL, INC.vChem®10 SG Urine Chemistry Strips2016-09-07