FDA.reportPublic FDA data

Uric acid IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of uric acid in a clinical specimen.
GUDID devices
78
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816042014116FORAFORA CARE INC.6 Connect2023-06-26
00816042014192FORAFORA CARE INC.Test N'GO Advance2023-06-26
00816042015250FORAFORA CARE INC.6 Connect/Test N'GO Advance/Test N'GO Advance Voic2024-09-23
00886338000048UASure II Blood Uric Acid Test Strips 25sAPEX BIOTECHNOLOGY CORP.S56409972021-12-27
05204309070923Uric AcidMEDICON HELLAS S.A.1418-00572026-04-27
05204309087419Uric AcidMEDICON HELLAS S.A.1419-00522026-04-27
06971674863922BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:20mL×1 R2:5mL×12023-07-13
06971674863939BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:80mL×1 R2:20mL×12023-07-13
06971674863953BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:48mL×2 R2:12mL×22023-07-13
06971674863984BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:100mL×1 R2:25mL×12023-07-13
06971674863991BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:48mL×2 R2:24mL×12023-07-13
06971674864004BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:48mL×2 R2:24mL×12023-07-13
06971674864035BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:48mL×2 R2:12mL×22023-07-13
06971674864059BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:48mL×2 R2:12mL×22023-07-13
06971674864066BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:48mL×2 R2:12mL×22023-07-13
06971674864073BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:48mL×2 R2:12mL×22023-07-13
16971404130949Blood Uric Acid Test Stripse-Linkcare Meditech Co., LtdSM4112021-12-17
80816042015256FORAFORA CARE INC.6 Connect/Test N'GO Advance/Test N'GO Advance Voic2024-09-23
00850053916168IDG/SanzayIDG/SANZAY Corporation12024-01-12
10673486002263Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSU582-1002023-11-30
10673486002300Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSU580-2402023-11-15
10673486002317Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSU580-4002023-11-15
10673486002324Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSU582-2502023-11-15
10673486002331Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240TECO DIAGNOSTICSU582-1170TC22023-11-15
10673486002348Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSU582-4802023-11-15
10673486002355Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-480TECO DIAGNOSTICSU582-1170TC42023-11-15
00850014861353HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)Hearts Bio, Inc.TD-42892023-08-08
06971674863908BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:64mL×2 R2:16mL×22023-07-14
06971674863915BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:20mL×4 R2:5mL×42023-07-14
06971674863946BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:40mL×4 R2:20mL×22023-07-14
06971674863960BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:80mL×2 R2:20mL×22023-07-14
06971674863977BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:20mL×4 R2:5mL×42023-07-14
06971674864011BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:64mL×6 R2:48mL×22023-07-14
06971674864028BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:20mL×4 R2:5mL×42023-07-14
06971674864042BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:20mL×4 R2:5mL×42023-07-14
80816042014112FORAFORA CARE INC.6 Connect2023-06-26
80816042014198FORAFORA CARE INC.Test N'GO Advance2023-06-26
00886338000031UASure II Blood Uric Acid Monitoring SystemAPEX BIOTECHNOLOGY CORP.S950462021-12-27
00886338000062UASure II Blood Uric Acid Test Strips 25sAPEX BIOTECHNOLOGY CORP.S56409972021-12-27
26971404130946Blood Uric Acid Test Stripse-Linkcare Meditech Co., LtdSM4112021-12-17
00811727015990Pointe Uric Acid ReagentHORIBA INSTRUMENTS INCORPORATED14-U7581-1602021-01-30
00811727016294Pointe Uric Acid ReagentHORIBA INSTRUMENTS INCORPORATED16-HU982-3082021-01-30
10758750000340VITROSORTHO-CLINICAL DIAGNOSTICS, INC.19439272020-05-16
05060500091477Synermed®INFRARED LABORATORY SYSTEMS LLCIR460-R2016-09-20
05060500091484Synermed®INFRARED LABORATORY SYSTEMS LLCIR460-X2016-09-20
05060500091491Synermed®INFRARED LABORATORY SYSTEMS LLCIR460-WK2016-09-20
05060500091507Synermed®INFRARED LABORATORY SYSTEMS LLCIR460-9112016-09-20
05060500091514Synermed®INFRARED LABORATORY SYSTEMS LLCIR461-L2016-09-20
05060500091521Synermed®INFRARED LABORATORY SYSTEMS LLCIR462-L2016-09-20
05060500091972Synermed®INFRARED LABORATORY SYSTEMS LLCIR460-12002017-02-28
00852169008263ClearChem Diagnostics Inc. Uric AcidCLEARCHEM DIAGNOSTICS INC.URA15002018-04-30
00852223007133ENZYMATIC URIC ACID STERLING DIAGNOSTICS INC2305-02016-09-14
00857969006464ACEALFA WASSERMANN, INC.RX10252017-10-10
00857969006518ACEALFA WASSERMANN, INC.SA10252017-10-10
00817274022115JAS DiagnosticsDREW SCIENTIFIC, INC.URI2-125U2016-09-12
00817274022122JAS DiagnosticsDREW SCIENTIFIC, INC.URI2-1LU2016-09-12
00817274022139JAS DiagnosticsDREW SCIENTIFIC, INC.URI2-1252016-09-12
00817274022146JAS DiagnosticsDREW SCIENTIFIC, INC.XL-URI2-402016-09-12
00817274022153JAS DiagnosticsDREW SCIENTIFIC, INC.URI2-BUL2016-09-12
00817274022160JAS DiagnosticsDREW SCIENTIFIC, INC.DG-URI2-1L2016-09-12
00817274022177JAS DiagnosticsDREW SCIENTIFIC, INC.DG-URI2-1252016-09-12
00817274022184JAS DiagnosticsDREW SCIENTIFIC, INC.URI2-1L2016-09-12
00817274022191JAS DiagnosticsDREW SCIENTIFIC, INC.URI2-BUP2016-09-12
00817274022207JAS DiagnosticsDREW SCIENTIFIC, INC.URIS-3U2016-09-12
00817439021342MedTest DX Uric Acid for the BS480Medtest Dx, Inc.UA4802016-09-27
00817439021366MedTest DX Uric Acid for the BS200Medtest Dx, Inc.UA6002016-09-27
00811727012166Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDU7581-1202016-08-31
00811727012173Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDU7581-5002016-08-31
00811727012180Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDU7581-1L2016-08-31
00811727012197Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDU7580-STD2016-08-31
00811727012791Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHU982-6152016-08-31
00811727013125Pointe Scientific, Inc. Uric AcidHORIBA INSTRUMENTS INCORPORATEDHU982-7292016-08-31
00811727013675Uric AcidHORIBA INSTRUMENTS INCORPORATED12-U7581-1202016-08-31
00811727014450Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-U7581-1202016-08-31
00811727014467Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATED13-U7581-5002016-08-31
00811727014849Pointe Scientific, Inc. Uric AcidHORIBA INSTRUMENTS INCORPORATEDHU982-12502016-08-31
00811727015136Pointe Scientific, Inc. Uric AcidHORIBA INSTRUMENTS INCORPORATEDOU982-7132016-08-31
00812137012050Uric Acid ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.500mL2016-10-12