FDA.reportPublic FDA data

Blood Ketone Control solution(level 3)

Primary DI
06971404131604
Brand
Blood Ketone Control solution(level 3)
Company
e-Linkcare Meditech Co., Ltd
Model
CM211
Device description
It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you are performing the test correctly.
Published
2022-05-17
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
06971404131604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971404131604069714041316046971404131604

GMDN Terms#

Term, Definition table
TermDefinition
Glucose/ketone 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 together for the quantitative measurement of glucose and ketones 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540481217
Device count
1
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
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
16971404131199Blood Ketone Test StripsSM3112021-12-17
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
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
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05