FDA.reportPublic FDA data

Urine sediment IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.
GUDID devices
91
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.871302026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.873272026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.873312026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.873322026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.873342026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.875282026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.875332026-04-17
00855617006743KOVAKOVA INTERNATIONAL, INC.871762020-08-12
00855617006750KOVAKOVA INTERNATIONAL, INC.871772020-08-12
00855617006767KOVAKOVA INTERNATIONAL, INC.878052020-08-12
00855617006835KOVAKOVA INTERNATIONAL, INC.881152020-08-12
00855617006842KOVAKOVA INTERNATIONAL, INC.881252020-08-12
00855617006859KOVAKOVA INTERNATIONAL, INC.882052020-08-12
00855617006866KOVAKOVA INTERNATIONAL, INC.881052020-08-12
00896863002035Chromascopics Control Level 1&2 Set 4x120mL (International)QUANTIMETRIX CORPORATION1540-012018-09-26
00896863002172Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 4x120mLQUANTIMETRIX CORPORATION1470-012018-09-26
00896863002264QuanTscopics Control Level 1 Set 4x120mLQUANTIMETRIX CORPORATION1481-412018-09-26
00896863002271QuanTscopics Control Level 2 Set 4x120mLQUANTIMETRIX CORPORATION1482-412018-09-26
00896863002370Dipper POCT Level 1&2 Set 62x1.5mL QUANTIMETRIX CORPORATION1400-012018-09-26
00896863002387Dipper POCT Level 1&2 Set 20x1.5mLQUANTIMETRIX CORPORATION1400-022018-09-26
00896863002394Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mLQUANTIMETRIX CORPORATION1470-022019-03-13
20612479214938McKessonMCKESSON MEDICAL-SURGICAL INC.163-891192020-04-16
20612479214945McKessonMCKESSON MEDICAL-SURGICAL INC.163-891162020-04-16
20612479214952McKessonMCKESSON MEDICAL-SURGICAL INC.163-892282020-04-16
20612479214969McKessonMCKESSON MEDICAL-SURGICAL INC.163-891232020-04-16
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)QUANTIMETRIX CORPORATION1540-032023-05-04
00850015517198SiemensKOVA INTERNATIONAL, INC.115616962022-03-03
00850015517204SiemensKOVA INTERNATIONAL, INC.115616952022-03-03
00850015517211SiemensKOVA INTERNATIONAL, INC.115616942022-03-03
00855617006545Cardinal HealthKOVA INTERNATIONAL, INC.892102020-09-04
00855617006224McKessonKOVA INTERNATIONAL, INC.891192020-09-03
00855617006248McKessonKOVA INTERNATIONAL, INC.891162020-09-03
00855617006279McKessonKOVA INTERNATIONAL, INC.891232020-09-03
00855617006460Cardinal HealthKOVA INTERNATIONAL, INC.892112020-09-03
00855617006477Cardinal HealthKOVA INTERNATIONAL, INC.892082020-09-03
00850015517167McKessonKOVA INTERNATIONAL, INC.892282020-09-02
00850015517099Cardinal HealthKOVA INTERNATIONAL, INC.892092020-08-19
00855617006774KOVAKOVA INTERNATIONAL, INC.871232020-08-11
00855617006262KOVAKOVA INTERNATIONAL, INC.87130E2020-08-10
00855617006286KOVAKOVA INTERNATIONAL, INC.87331E2020-08-10
00855617006316KOVAKOVA INTERNATIONAL, INC.87428E2020-08-10
00855617006620KOVAKOVA INTERNATIONAL, INC.87325E2020-08-10
00855617006637KOVAKOVA INTERNATIONAL, INC.871302020-08-10
00855617006644KOVAKOVA INTERNATIONAL, INC.873272020-08-10
00855617006651KOVAKOVA INTERNATIONAL, INC.873292020-08-10
00855617006668KOVAKOVA INTERNATIONAL, INC.873312020-08-10
00855617006675KOVAKOVA INTERNATIONAL, INC.873322020-08-10
00855617006682KOVAKOVA INTERNATIONAL, INC.873342020-08-10
00855617006699KOVAKOVA INTERNATIONAL, INC.871102020-08-10
00855617006705KOVAKOVA INTERNATIONAL, INC.871112020-08-10
00855617006712KOVAKOVA INTERNATIONAL, INC.87111E2020-08-10
00855617006729KOVAKOVA INTERNATIONAL, INC.871122020-08-10
00855617006736KOVAKOVA INTERNATIONAL, INC.871222020-08-10
00855617006309KOVAKOVA INTERNATIONAL, INC.87426E2020-07-31
00855617006323KOVAKOVA INTERNATIONAL, INC.87528E2020-07-31
00855617006330KOVAKOVA INTERNATIONAL, INC.87533E2020-07-31
00855617006347KOVAKOVA INTERNATIONAL, INC.874262020-07-31
00855617006354KOVAKOVA INTERNATIONAL, INC.87426Q2020-07-31
00855617006361KOVAKOVA INTERNATIONAL, INC.874282020-07-31
00855617006378KOVAKOVA INTERNATIONAL, INC.87428Q2020-07-31
00855617006385KOVAKOVA INTERNATIONAL, INC.875282020-07-31
00855617006392KOVAKOVA INTERNATIONAL, INC.87528Q2020-07-31
00855617006408KOVAKOVA INTERNATIONAL, INC.875332020-07-31
00855617006415KOVAKOVA INTERNATIONAL, INC.87533Q2020-07-31
00855617006422KOVAKOVA INTERNATIONAL, INC.87128Q2020-07-31
00855617006439KOVAKOVA INTERNATIONAL, INC.370362020-07-31
00855617006446KOVAKOVA INTERNATIONAL, INC.872222020-07-31
00855617006453KOVAKOVA INTERNATIONAL, INC.87222E2020-07-31
00850015517136KOVAKOVA INTERNATIONAL, INC.42552020-07-30
00850015517143KOVAKOVA INTERNATIONAL, INC.42632020-07-30
00850015517150KOVAKOVA INTERNATIONAL, INC.42652020-07-30
00855617006002KOVAKOVA INTERNATIONAL, INC.87112E2020-07-30
00855617006019KOVAKOVA INTERNATIONAL, INC.87122E2020-07-30
00855617006026KOVAKOVA INTERNATIONAL, INC.87176E2020-07-30
00855617006033KOVAKOVA INTERNATIONAL, INC.87123E2020-07-30
00855617006040KOVAKOVA INTERNATIONAL, INC.87177E2020-07-30
00855617006200KOVAKOVA INTERNATIONAL, INC.87329E2020-07-30
00855617006217KOVAKOVA INTERNATIONAL, INC.87325E2020-07-30
00855617006231KOVAKOVA INTERNATIONAL, INC.87332E2020-07-30
00855617006255KOVAKOVA INTERNATIONAL, INC.87334E2020-07-30