FDA.reportPublic FDA data

Total cholesterol lipid 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 total cholesterol lipid in a clinical specimen.
GUDID devices
63
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816042014178FORAFORA CARE INC.Test N'GO Advance2023-06-26
00816042014864FORAFORA CARE INC.6 Connect2023-06-26
00816042015205FORAFORA CARE INC.6 Connect/GTel/Test N'GO Advance/Test N'GO Advnace2025-03-14
00816042016387FORAFORA CARE INC.Test N'GO Advance/Test N'GO Advance Voice2026-04-27
00850014861346HeartsCare C1 Total Cholesterol Test Strip (10pcs/box)Hearts Bio, Inc.TD-42892022-04-11
00850014861834heartscare Total Cholesterol Test Strip (10pcs/box)Hearts Bio, Inc.TD-42892026-04-17
04719893233834XPER Technology Procheck Witty Procheck Smart Total Cholesterol Test StripsTAIDOC TECHNOLOGY CORPORATIONTD-46422025-10-30
80816042015201FORAFORA CARE INC.6 Connect/GTel/Test N'GO Advance/Test N'GO Advnace2025-03-14
08806141303701Newfoundland Cholesterol TestDFI CO.,LTD64502024-05-29
10673486001419Teco Diagnostics Cholesterol TC-Matrix-240TECO DIAGNOSTICSC507-940TC22023-08-01
10673486001426Teco Diagnostics Cholesterol TC-Matrix-480TECO DIAGNOSTICSC507-940TC42023-08-01
06936895301882BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:64mL×2 R2:16mL×22023-07-26
06936895301899BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:20mL×1 R2:5mL×12023-07-26
06936895301905BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:20mL×4 R2:5mL×42023-07-26
06936895301912BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R1:60mL×5 R2:15mL×52023-07-26
10673486001457Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSC509-1502023-07-26
10673486001464Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSC509-4002023-07-26
10673486001471Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSC509-1L2023-07-26
10673486001402Teco Diagnostics Cholesterol (Liquid) Reagent SetTECO DIAGNOSTICSC507-1002023-07-25
10673486001433Teco Diagnostics Cholesterol (Liquid) Reagent SetTECO DIAGNOSTICSC507-4802023-07-25
10673486001440Teco Diagnostics Cholesterol TC MatrixTECO DIAGNOSTICSC507-940TM2023-07-25
06971674860013BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:70mL×22023-07-08
06971674860020BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:60mL×22023-07-08
06971674860037BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×82023-07-08
06971674860044BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×22023-07-08
06971674860051BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R120mL×12023-07-08
06971674860068BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×4 2023-07-08
06971674860075BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-08
06971674860082BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:80mL×22023-07-08
06971674860099BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-08
06971674860105BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:100mL×22023-07-08
06971674860112BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:50mL×42023-07-08
06971674860129BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-08
06971674860136BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-08
06971674860143BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:70mL×82023-07-08
06971674860150BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×82023-07-08
06971674860167BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-08
06971674860174BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:20mL×82023-07-08
06971674860181BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-08
06971674860198BIOBASEBiobase Biodustry(Shandong)Co., Ltd.R:40mL×42023-07-08
80816042014174FORAFORA CARE INC.Test N'GO Advance2023-06-26
80816042014860FORAFORA CARE INC.6 Connect2023-06-26
08806141302896QUCARE®Self Total Cholesterol DFI CO.,LTD64072022-07-26
08806141302674QUCARE®Self Total Cholesterol DFI CO.,LTD6400P2022-07-25
10758750009527VITROSORTHO-CLINICAL DIAGNOSTICS, INC.16698292020-04-18
00380740161682ARCHITECTAbbott GmbH7D62-222020-01-25
05060500090579Synermed®INFRARED LABORATORY SYSTEMS LLCIR060-R2016-09-20
05060500090586Synermed®INFRARED LABORATORY SYSTEMS LLCIR060-X2016-09-20
05060500090593Synermed®INFRARED LABORATORY SYSTEMS LLCIR060-WK2016-09-20
05060500090609Synermed®INFRARED LABORATORY SYSTEMS LLCIR060-9112016-09-20
05060500090616Synermed®INFRARED LABORATORY SYSTEMS LLCIR061-L2016-09-20
05060500090623Synermed®INFRARED LABORATORY SYSTEMS LLCIR062-L2016-09-20
05060500091859Synermed®INFRARED LABORATORY SYSTEMS LLCIR060-12002017-02-28
00852169008157ClearChem Diagnostics Inc. Cholesterol, TotalCLEARCHEM DIAGNOSTICS INC.CHL11002018-04-30
00852223007003ENZYMATIC CHOLESTEROLSTERLING DIAGNOSTICS INC2145-L2016-09-14
00852223007010ENZYMATIC CHOLESTEROLSTERLING DIAGNOSTICS INC2145-02016-09-14
00852223007201SUPER SENSITIVE CHOLESTEROLSTERLING DIAGNOSTICS INC2147-02016-09-14
00857969006440ACEALFA WASSERMANN, INC.RX10102017-10-10
00857969006488ACEALFA WASSERMANN, INC.SA10102017-10-10
00812137011930Cholesterol ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.500mL2016-10-12
00657498001141Cholesterol Standard (200 mg/dL)STANBIO LABORATORY, L.P.1012-0302016-09-23
00380740012861ARCHITECTABBOTT LABORATORIES7D62-212016-06-06
00380740132606AlinityAbbott GmbH07P76202018-07-11