Blood Ketone Test Strips

GUDID 26971404131196

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.

e-Linkcare Meditech Co., Ltd

Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent Glucose/ketone/lipid profile IVD, reagent
Primary Device ID26971404131196
NIH Device Record Keyc75f1d8b-cb44-485e-a1fc-7c2e95feac66
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood Ketone Test Strips
Version Model NumberSM311
Company DUNS540481217
Company Namee-Linkcare Meditech Co., Ltd
Device Count15
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106971404131192 [Unit of Use]
GS116971404131199 [Primary]
GS126971404130939 [Package]
Contains: 16971404131199
Package: Box [30 Units]
In Commercial Distribution
GS126971404131196 [Package]
Contains: 16971404131199
Package: Box [15 Units]
In Commercial Distribution
GS136971404130004 [Package]
Contains: 26971404130939
Package: carton [100 Units]
In Commercial Distribution
GS136971404130011 [Package]
Package: carton [160 Units]
In Commercial Distribution
GS136971404130936 [Package]
Contains: 26971404130939
Package: Carton [160 Units]
In Commercial Distribution
GS136971404131193 [Package]
Package: carton [100 Units]
In Commercial Distribution

FDA Product Code

JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-27
Device Publish Date2021-12-17

Devices Manufactured by e-Linkcare Meditech Co., Ltd

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06971404131598 - Blood Ketone Control solution(level 2)2022-05-25 It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you a
06971404131604 - Blood Ketone Control solution(level 3)2022-05-25 It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you a
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06971404131628 - Uric Acid Control solution(level 2)2022-05-25 It is used to confirm that your Blood Uric Acid Test Strips and Multi-Monitoring Meter are working together properly and that yo
16971404130918 - Blood Ketone Monitoring System2021-12-27 Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxyb
16971404130925 - Blood Uric Acid Monitoring System2021-12-27 Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric
26971404130946 - Blood Uric Acid Test Strips2021-12-27 Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric

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