FDA.reportPublic FDA data

Multiple urine analyte IVD, control

Definition
A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.
GUDID devices
189
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00612479197411McKessonMCKESSON MEDICAL-SURGICAL INC.121-0112019-03-18
00612479197435McKessonMCKESSON MEDICAL-SURGICAL INC.121-0712019-03-18
00682607200672Mission Liquid Urine ControlsAcon Laboratories, Inc.U021-0112025-04-17
00682607200689Mission Liquid Urine ControlsAcon Laboratories, Inc.U021-0112025-04-17
00682607200696Mission Liquid Urine ControlsAcon Laboratories, Inc.U021-0712025-04-17
00682607200702Mission Liquid Urine ControlsAcon Laboratories, Inc.U021-0712025-04-17
00810142890007NLCP Urine PTResearch Triangle Institute Inc012024-01-08
00896863002103Microbumin Microalbumin Control Level 1&2 Set 10x7mLQUANTIMETRIX CORPORATION1250-012018-09-26
00896863002110Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mLQUANTIMETRIX CORPORATION1440-022018-09-26
00896863002127Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mLQUANTIMETRIX CORPORATION1440-032018-09-26
00896863002134Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mLQUANTIMETRIX CORPORATION1440-012018-09-26
00896863002141Dipper Urinalysis Dipstick Control Level 2 Set 6x15mLQUANTIMETRIX CORPORATION1442-612018-09-26
00896863002158Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mLQUANTIMETRIX CORPORATION1440-042018-09-26
00896863002165Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mLQUANTIMETRIX CORPORATION1440-062018-09-26
00896863002189Dropper Urine Chemistry Control Level 1&2 Set 2x10mLQUANTIMETRIX CORPORATION1430-012018-09-26
00896863002196Dropper Urine Chemistry Control Level 1 Set 3x10mLQUANTIMETRIX CORPORATION1431-312018-09-26
00896863002202Dropper Urine Chemistry Control Level 1 Set 3x25mLQUANTIMETRIX CORPORATION1431-322018-09-26
00896863002219Dropper Urine Chemistry Control Level 2 Set 3x10mLQUANTIMETRIX CORPORATION1432-312018-09-26
00896863002226Dropper Urine Chemistry Control Level 2 Set 3x25mLQUANTIMETRIX CORPORATION1432-322018-09-26
03610230005248ABX PENTRA URINE CONTROL L/HHORIBA ABX SAS12200016742016-08-16
06935740750653Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.URIT YC 2ST,C-SG and C-TUR(C-SG:2×8mL, C-TUR:2×8mL2026-04-16
06935740750660Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.URIT YC 2ST,C-SG(2×8mL)2026-04-16
06935740750677Calibrator Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.URIT YC 2ST,C-TUR(2×8mL)2026-04-16
06935740750684Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.URIT YQ 3STC2026-04-16
06935740750691Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.URIT YQ 3STC,COL(Red:1×8mL,Yellow:1×8mL,Green:1×8m2026-04-16
06935740750707Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.URIT YQ 3STC,TUR(Level 1:1×8mL,Level 2:1×8mL)2026-04-16
06935740750714Quality Control Solution For Urine AnalyzerUrit Medical Electronic Co., Ltd.URIT YQ 3STC,SG(Level 1:1×8mL,Level 2:1×8mL,Level 2026-04-16
06935740750721Urinalysis ControlUrit Medical Electronic Co., Ltd.UQ-14,NO.I:8mL,NO.II:8mL,NO.III:8mL2026-04-16
10858512007003NAALTA DIAGNOSTICS INC301-12019-03-29
10858512007010NAALTA DIAGNOSTICS INC301-22019-03-29
10858512007041NAALTA DIAGNOSTICS INC303-22019-03-29
10858512007089NAALTA DIAGNOSTICS INC323-16-12019-03-29
10858512007096NAALTA DIAGNOSTICS INC323-16-22019-03-29
10858512007119NAALTA DIAGNOSTICS INC323-17-12019-03-29
10858512007126NAALTA DIAGNOSTICS INC323-17-22019-03-29
10885380151903CARDINAL HEALTHCardinal Health 200, LLCCHUA1152019-05-16
10885380151910CARDINAL HEALTHCardinal Health 200, LLCCHUA1602019-05-16
10885380151927CARDINAL HEALTHCardinal Health 200, LLCCHUA2152019-05-16
10885380151934CARDINAL HEALTHCardinal Health 200, LLCCHUA2602019-05-24
10888439028454CARDINAL HEALTHCardinal Health 200, LLCPVMHCB3352018-06-22
B085K090M80Audit MicroControls Control FD for bioMérieux VIDAS® NEPHROCLEAR CCL14AALTO SCIENTIFICK090M-82024-12-16
B800NICUFUCSF0NICOTINE PLUSUTAK LABORATORIES, INC.NIC+ U F UCSF2023-03-16
B085K829M100Audit MicroControls Linearity FD Urine Chemistry for Beckman AUAALTO SCIENTIFICK829M-102025-11-20
20682607200676Mission Liquid Urine ControlsACON LABORATORIES, INC.U021-0112025-04-17
20682607200683Mission Liquid Urine ControlsACON LABORATORIES, INC.U021-0112025-04-17
20682607200690Mission Liquid Urine ControlsACON LABORATORIES, INC.U021-0712025-04-17
20682607200706Mission Liquid Urine ControlsACON LABORATORIES, INC.U021-0712025-04-17
06971257037177urinalysis stripsWeihai Kangzheng Medical Equipment Technology Co., Ltd3T2024-06-22
B085K897M50Audit MicroControls Linearity FD Urine Chemistry Panel 1 for Abbott SystemsAALTO SCIENTIFICK897M-52024-04-09
B085K898M50Audit MicroControls Linearity FD Urine Chemistry Panel 2 for Abbott SystemsAALTO SCIENTIFICK898M-52024-04-09
10837461002611IRISpecBECKMAN COULTER IRELAND INC.CA/CB/CC URINE CHEMSITRY CONTROLS2016-09-07
10837461002680IRISpecBECKMAN COULTER IRELAND INC.CA/CB/CC URINE CHEMSITRY CONTROLS2016-09-07
10837461002710iChem® VELOCITY™BECKMAN COULTER IRELAND INC.CalChek Kit2016-09-07
10837461001973IRISpecIRIS INTERNATIONAL, INC.CA/CB Twinset2016-09-07
10837461008002AX-4280IRIS INTERNATIONAL, INC.Specific Gravity Calibrator Set (NA)2016-09-07
00810042683518iScreenBIOCHEMICAL DIAGNOSTICS INC880192023-06-13
B800CDFU1LSMA0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.CDF U 1L SMA2023-04-04
B800NICUFUCSF5NICOTINE PLUSUTAK LABORATORIES, INC.NIC+ U F UCSF2023-03-16
00850011135525ValidateLgc Clinical Diagnostics, Inc.701re2023-02-06
05055273207569LIQUID URINE CONTROL - LEVEL 2 (LIQ URN CONTROL 2)RANDOX LABORATORIES LIMITEDUC50742022-10-05
05055273207576LIQUID URINE CONTROL - LEVEL 3 (LIQ URN CONTROL 3)RANDOX LABORATORIES LIMITEDUC50752022-10-05
05055273207583URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1)RANDOX LABORATORIES LIMITEDUC50332022-10-05
05055273207590URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2)RANDOX LABORATORIES LIMITEDUC50342022-10-05
10634853000589Microorganism PelletsMICROBIOLOGICS INC.URI-KIT2022-09-26
00850011135334ValidateLgc Clinical Diagnostics, Inc.701ab2021-06-28
00850011135341ValidateLgc Clinical Diagnostics, Inc.704ab2021-06-28
00850011135358ValidateLgc Clinical Diagnostics, Inc.705ab2021-06-28
B085K828M50Audit MicroControls Linearity FLQ Urine/Fluids Chemistry for Beckman AUAALTO SCIENTIFICK828M-52021-05-05
00850004812501Adulter-SkreenBIOCHEMICAL DIAGNOSTICS INC203000022020-10-20
03610230007877Yumizen C Urine Level 1 ControlHORIBA ABX SAS 1300023946 2020-09-16
03610230007884Yumizen C Urine Level 2 ControlHORIBA ABX SAS 1300023947 2020-09-16
00847661000549LiquichekBIO-RAD LABORATORIES, INC.4362020-09-14
00847661000556LiquichekBIO-RAD LABORATORIES, INC.4372020-09-14
00847661000563LiquichekBIO-RAD LABORATORIES, INC.4352020-09-14
00847661001478LyphochekBIO-RAD LABORATORIES, INC.3762020-09-14
00847661001485LyphochekBIO-RAD LABORATORIES, INC.3772020-09-14
00847661002000LyphochekBIO-RAD LABORATORIES, INC.375X2020-09-14
00847661003229qUAntifyBIO-RAD LABORATORIES, INC.9622020-09-14
00847661003236qUAntifyBIO-RAD LABORATORIES, INC.962X2020-09-14
00847661003243qUAntifyBIO-RAD LABORATORIES, INC.9632020-09-14