FDA.reportPublic FDA data

Oh’Care Lite Blood Glucose Monitoring System Kit

Primary DI
00793150629763
Brand
Oh’Care Lite Blood Glucose Monitoring System Kit
Company
OSANG HEALTHCARE Co., Ltd.
Model
IGM-1003A
Device description
Blood Glucose Monitoring System Kit
Published
2017-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132966000GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMInfopia Co, Ltd.2013-12-05NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00793150629763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00793150629763007931506297637931506297630793150629763

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.5Microliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-925-2949support@ijdream.com

Regulatory Flags#

DUNS number
688195374
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809115905796Oh'care Lite Smart Glucose Test StripIGM-1003F2020-11-05
08809115908438Element™ Test StripsIGM-0021B2017-12-11
08809115908957Element™Plus Test StripsIGM-0021B2017-07-21
08809115905369OKRA Glucose Test Strip(25T)IGM-1003A2021-07-27
08809115905697OKRA Glucose Test Strip Refill kitIGM-1003A2020-10-29
08809115905710OKRA Glucose Test StripIGM-1003A2020-10-29
08809115906540Oh'Care Lite Smart Glucose Test StripIGM-1003F2019-09-17
00793150629787Oh’Care Lite Blood Glucose Test stripsIGM-1003AINFS003L2017-11-03
08809115900449QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC02ENA12025-03-18
08809115900401QuickFinder™ COVID-19/Flu Antigen Pro Control Swab KitOI-01SQ-C1RCQC110ENA12025-03-12
08809115900418QuickFinder™ COVID-19/Flu Antigen ProTestOI-01SU-CCRCUCC25ENP12025-03-18
08809115900425QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC05ENA12025-03-18
08809115900432QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC04ENA12025-03-18
08809115900456QuickFinder™ COVID-19/Flu Antigen Self TestOI-01SU-CCRCUCC01ENA12025-03-17
08809115904119CURO L5 Glucose test stripILM-0001AINFSG001EF2022-09-26
08809115905406CURO L5 MeterILM-0001A2021-07-09
08809115905413CURO L5 TC test stripILM-0001A2021-07-09
08809115905444CURO L5 TG test stripILM-0001A2021-06-17
08809115905703OKRA Glucose monitoring system starter kitIGM-1003A2020-10-29
08809115905727OKRA Glucose meterIGM-1003A2020-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750035823VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-08-26
00850011135884VALIDATELgc Clinical Diagnostics, Inc.JJX2026-08-25
04719869706966medisana BG 150 Blood Glucose MeterTYSON BIORESEARCH INC.NBW2026-08-19
04719869707000BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707017BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707024BG 150 Blood Glucose Test Strip(50T)TYSON BIORESEARCH INC.NBW2026-08-19
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCNBW2026-08-13
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJX2026-08-13
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850075956777Refractrol SP NormalLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956784Refractrol SP 9.0 HighLgc Clinical Diagnostics, Inc.JJX2026-07-30