FDA.reportPublic FDA data

Blood Ketone Test Strips

Primary DI
16971404131199
Brand
Blood Ketone Test Strips
Company
e-Linkcare Meditech Co., Ltd
Model
SM311
Device description
Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxybutyrate (B -ketone) in fresh capillary whole blood or venous whole blood.
Published
2021-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26971404130939PackageGS130In Commercial Distribution
26971404131196PackageGS115In Commercial Distribution
36971404130004PackageGS1100In Commercial Distribution
36971404130011PackageGS1160In Commercial Distribution
36971404130936PackageGS1160Not in Commercial Distribution
36971404131193PackageGS1100Not in Commercial Distribution
16971404131199PrimaryGS10
06971404131192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697140413093926971404130939
2697140413119626971404131196
3697140413000436971404130004
3697140413001136971404130011
3697140413093636971404130936
3697140413119336971404131193
1697140413119916971404131199
06971404131192069714041311926971404131192

GMDN Terms#

Term, Definition table
TermDefinition
Glucose/ketone/lipid profile IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile.

Regulatory Flags#

DUNS number
540481217
Device count
15
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971404130911Blood Ketone Monitoring SystemPM900B2021-12-17
06971404131581Blood Ketone Control solution(level 1)CM2112022-05-17
06971404131598Blood Ketone Control solution(level 2)CM2112022-05-17
06971404131604Blood Ketone Control solution(level 3)CM2112022-05-17
06971404131611Uric Acid Control solution(level 1)CM3112022-05-17
06971404131628Uric Acid Control solution(level 2)CM3112022-05-17
06971404130928Blood Uric Acid Monitoring SystemPM900C2021-12-17
16971404130949Blood Uric Acid Test StripsSM4112021-12-17
16971404130918Blood Ketone Monitoring SystemPM900B2021-12-17
16971404130925Blood Uric Acid Monitoring SystemPM900C2021-12-17
26971404130946Blood Uric Acid Test StripsSM4112021-12-17
26971404131196Blood Ketone Test StripsSM3112021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIN2026-04-16
00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-07-02
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-03-31
00816042015199FORAFORA CARE INC.JIN2025-03-14
00850054026729QMedix™Diagnostic Automation, Inc.JIN2024-10-29
00816042015069FORAFORA CARE INC.JIN2024-10-01
00816042015076FORAFORA CARE INC.JIN2024-10-01
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06