FDA.reportPublic FDA data

Ketone (acetoacetate) 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 qualitative and/or quantitative detection of ketone (acetoacetate) in a clinical specimen.
GUDID devices
31
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00717931142234ketodoc B-Ketone Test Strips (40PCS/BOX)Rediston LimitedTD-41412025-10-09
00816042015069FORAFORA CARE INC.GTel/Test N'GO Advance/Test N'GO Advance Voice/Tes2024-10-01
00816042015076FORAFORA CARE INC.GTel/Test N'GO Advance/Test N'GO Advance Voice/Tes2024-10-01
00816042015199FORAFORA CARE INC.6 Connect/GTel/Test N'GO Advance/Test N'GO Advnace2025-03-14
00816042016417FORAFORA CARE INC.GTel/Test N'GO Advance/Test N’GO Advance Voice/Tes2026-03-20
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.TD-42892025-10-01
00885325000863KetoSensi-SENS, Inc.2761512020-11-10
00885325000870KetoSensi-SENS, Inc.276153-2062020-11-10
00885325001068KetoSensi-SENS, Inc.2761542020-11-10
00885325001075KetoSensi-SENS, Inc.2762622020-11-10
00885325001198KetoSensi-SENS, Inc.2761502020-11-10
00885325001273KetoSensi-SENS, Inc.2761552020-11-10
00885325001280KetoSensi-SENS, Inc.2761562020-11-10
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTAIDOC TECHNOLOGY CORPORATIONTD-46312025-10-30
00199284689879SureMediks B-Ketone Test Strips (25pcs/box)Rasimo Systems LLCTD-4279D2025-12-05
80816042015195FORAFORA CARE INC.6 Connect/GTel/Test N'GO Advance/Test N'GO Advnace2025-03-14
80816042015065FORAFORA CARE INC.GTel/Test N'GO Advance/Test N'GO Advance Voice/Tes2024-10-01
80816042015072FORAFORA CARE INC.GTel/Test N'GO Advance/Test N'GO Advance Voice/Tes2024-10-01
00850017460089BIOCOACH Blood Ketone Test Strips 50 Pack (Foil)AMVENTUREX, INC.S56409342023-05-31
00703674534498ketodoc B-Ketone Test Strips (40PCS/BOX)Rediston LimitedTD-41412023-03-17
00860001641752KetoBMKetobm LLCKBM-K012022-11-21
00860182000645KetoBMKetobm LLCKS-012022-11-21
00860005745913bkt ß-Ketone Test Strips (50 pcs/box)Adam LawrenceTD-42792022-10-13
00860005745906bkt ß-Ketone Test Strips (100 pcs/box)Adam LawrenceTD-42792020-12-22
00657498002131Nitro-tab Ketone TabletsSTANBIO LABORATORY, L.P.4000-1002019-03-11
00840937105658Immunalysis CorporationIMMUNALYSIS CORPORATIONCB-4452016-08-31
00860060002327KETOCOACH 50 BLOOD KETONE TEST STRIPSAMVENTUREX, INC.S56407912019-12-30
00851225008025Lucidplus B-Ketone Test Strips 50 countVIDAN DIAGNOSTICS LLC3100-0502018-12-06
00858538007004keto mojo β-ketone test strips (50pcs/box)KETO-CHECK, INC.TD-42792019-02-21
00858538007202Keto-mojo β-ketone test strips (10pcs/box)KETO-CHECK, INC.TD-42792019-02-21
00695684131005AIMTAB KETONE TABLETSGERMAINE LABORATORIES, INC131002016-04-27