FDA.reportPublic FDA data

Glucose IVD, kit, electrometry

Definition
A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).
GUDID devices
121
Last updated
2026-08-28 10:31:18

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04719869707024BG 150 Blood Glucose Test Strip(50T)TYSON BIORESEARCH INC.BG 1502026-08-19
06939184600178biolandBioland Technology Ltd.Bioland2021-01-20
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.Tyson Bio AC500 PRO2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.BG 1502026-07-13
00850044118205iHealthiHealth Labs Inc.EGS-20032023-08-24
00850044118250iHealthiHealth Labs Inc.EGS-20032023-08-30
00850044118267iHealthiHealth Labs Inc.EGS-20032023-08-30
00856362005197iHealthiHealth Labs Inc.EGS-20032019-01-09
00860003222317Center Health Blood Glucose Test Strips (50pcs/bot)CENTER HEALTH INCORPORATEDTD-41402020-03-17
00041220865468H-E-B inControlH. E. BUTT GROCERY COMPANYG202016-12-13
00193169642300TruePointOK BIOTECH CO., LTD.642302018-09-28
00311917064635WalgreensWALGREEN CO.351587 2025-06-20
00353885004183OneTouch Ultra BlueLifeScan U.S. LLC020-9632017-09-13
00353885007726OneTouch VerioLifeScan Europe GmbH022-2692017-09-13
00353885007733OneTouch VerioLifeScan Europe GmbH022-2702017-09-13
00353885008853OneTouch Ultra2LifeScan Europe GmbH021-1002017-09-13
00353885009713OneTouch Ultra BlueLifeScan U.S. LLC022-8952017-09-13
00353885009720OneTouch Ultra BlueLifeScan U.S. LLC022-8962017-09-13
00353885009751OneTouch VerioLifeScan Europe GmbH022-8982017-09-13
00353885009768OneTouch VerioLifeScan Europe GmbH022-8992017-09-13
00353885010016OneTouch Ultra2LifeScan Europe GmbH022-9652017-09-13
00353885010030OneTouch VerioLifeScan Europe GmbH022-9782017-09-13
00353885010481OneTouch VerioLifeScan Europe GmbH023-0612017-09-13
00353885011556OneTouch VerioLifeScan Europe GmbH011-8172017-09-13
00353885011563OneTouch Ultra BlueLifeScan Europe GmbH011-4242017-09-13
00353885011570OneTouch Ultra BlueLifeScan Europe GmbH011-4242017-09-13
00353885012034OneTouch VerioLifeScan Europe GmbH024-1742020-04-12
00353885012188OneTouch VerioLifeScan Europe GmbH024-1832020-06-30
00353885012423OneTouch VerioLifeScan Europe GmbH013-0462021-09-18
00353885012591OneTouch VerioLifeScan Europe GmbH024-2652022-03-31
00353885012614OneTouch VerioLifeScan Europe GmbH024-2692022-08-31
00353885012638OneTouch Ultra PlusLifeScan Europe GmbH024-2712022-08-31
00353885012652OneTouch Ultra Blue Test StripsLifeScan U.S. LLC024-2732022-07-28
00353885012782OneTouch VerioLifeScan Europe GmbH024-3282022-12-23
00353885013000OneTouch UltraLifeScan U.S. LLC024-3912025-06-20
00353885994255OneTouch Ultra BlueLifeScan U.S. LLC020-9942017-09-13
00370393210202Care TouchFUTURE DIAGNOSTICS LLCCT2102018-02-05
00370393211056Care TouchFUTURE DIAGNOSTICS LLCCT-502018-02-05
00383568100819CareLiving Blood Glucose Test Strips 100ctCare Living Diagnostics Inc.CL-1002023-11-15
00383568100857CareLiving Blood Glucose Test Strips 50ct Care Living Diagnostics Inc.CL-502023-11-15
00384840104006Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLC0104002024-07-10
00384840528253Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLC0528252016-09-21
00384840725003Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLC0725002016-09-21
00384840732001Prodigy No Coding Blood Glucose Test StripsProdigy Diabetes Care, LLC0732002016-09-21
00389167248501UniStrip1 Generic Blood Glucose Test StripUnistrip Technologies, LLC0248502016-09-24
00681131104869Equate Blood Glucose Test StripsUnistrip Technologies, LLC0386002016-09-24
00717931142241ketodoc Blood Glucose Test Strips (40PCS/BOX)Rediston LimitedTD-41412025-10-09
00738629167476ANKOVO TD-4267 Blood Glucose Test Strips 100PCSMETENE LIMITEDTD-42672020-06-10
00810038634869Easy@Home Blood Glucose Test StripHMD BIOMEDICAL INC.3S-01-2500382023-03-15
00810038636061Easy@Home EBG-100BLE blood glucose monitoring systemHMD BIOMEDICAL INC.3K-01-25003G2024-07-17
00810038636894Easy@Home EBG-100BLE Blood Glucose Test StripHMD BIOMEDICAL INC.3S-01-25003F2024-07-17
00816042013577FORAFORA CARE INC.GTel/Test N'GO Advance/Test N'GO Advance Voice/Goj2020-12-22
00816042013669FORAFORA CARE INC.Test N'GO Advance Pro 2020-05-05
00816042013881ForaCareFORA CARE INC.GD202020-04-06
00816042013911FORAFORA CARE INC.G202023-07-03
00816042015038FORAFORA CARE INC.GTel/Test N'GO Advance/Test N'GO Advance Voice/Tes2024-10-01
00850048540491LPOW blood glucose monitoring system(Meter)HMD BIOMEDICAL INC.3K-01-25003E2023-09-28
00860002137926GenUltimate Zephyr!PHARMA TECH SOLUTIONS, INC.104-502019-09-09
00860002137933GenUltimate Zephyr!PHARMA TECH SOLUTIONS, INC.104-102019-09-09
00860002137964Alltara Zephyr!PHARMA TECH SOLUTIONS, INC.103-502019-09-09
00885017000171EasyMax 15 Blood Glucose Test StripEPS BIO TECHNOLOGY CORP.EM442018-10-12
00891237001195Easy Step Blood Glucose Test Strips 50ctHOME AIDE DIAGNOSTICS, INC.T5D2-002016-05-03
00891237001423Easy Trak Blood Glucose Test Strips 25ctHOME AIDE DIAGNOSTICS, INC.2000200492016-05-03
00891237001485Easy Talk Blood Glucose Testing Strips 25ctHOME AIDE DIAGNOSTICS, INC.88182016-05-03
00891237001645Easy Plus II Blood Glucose Testing Strips 25ctHOME AIDE DIAGNOSTICS, INC.88182016-05-03
00894046001578Advocate Redi- Code+ Test Strips for Blood Glucose 50 CountDIABETIC SUPPLY OF SUNCOAST, INC.BMB0022016-08-19
00894046001875Advocate Redi-Code+ Test Strips for Blood Glucose 35 CountDIABETIC SUPPLY OF SUNCOAST, INC.BMB002-352016-08-19
03760165449232BEWELL CONNECT MyGluco Test StripVISIOMED GROUPBW-STGL12017-05-12
04260236850244FIA Salut CS06HMD BIOMEDICAL INC.3K-01-14003162020-07-06
04260236850329PRECICHEK AutoCode foil packed test stripHMD BIOMEDICAL INC.3L-10-1600312020-07-01
04260236850367FIA Salut foil packed test stripHMD BIOMEDICAL INC.3L-10-1400332020-07-08
04260236850411PRECICHEK AutoCode vial packed test StripHMD BIOMEDICAL INC.3S-01-1600322020-05-12
04260236850459FIA Salut foil packed test strip(for SS)HMD BIOMEDICAL INC.3L-10-14003A2020-07-17
04260236850466FIA Salut vial packed test stripHMD BIOMEDICAL INC.3S-01-14003352020-07-06
04260236850480FIA Salut vial packed test stripHMD BIOMEDICAL INC.3S-01-14003342020-07-08
04260236850619PRECICHEK AutoCode AC302HMD BIOMEDICAL INC.3K-01-16003A2020-07-06
04260236850664PRECICHEK AutoCode foil packed test stripHMD BIOMEDICAL INC.3L-10-16003D2020-07-06
04260236850848FIA Salut vial packed test strip(for Elhenawy)HMD BIOMEDICAL INC.3S-01-1409962020-07-17
04260236850916PRECICHEK AutoCode vial packed test stripHMD BIOMEDICAL INC.3S-01-16003F2020-07-06
04260236851005FIA Salut vial packed test strip(for SS)HMD BIOMEDICAL INC.3S-01-1400A12020-07-17