TysonBio EVOLVE Blood Glucose Test Strips (25T)

GUDID 24719869701057

TYSON BIORESEARCH INC.

Glucose IVD, kit, electrometry
Primary Device ID24719869701057
NIH Device Record Key5ecadb71-33a3-4196-8d6e-78bfe00781d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTysonBio EVOLVE Blood Glucose Test Strips (25T)
Version Model NumberTysonBio EVOLVE
Company DUNS658026104
Company NameTYSON BIORESEARCH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719869701053 [Primary]
GS114719869701050 [Package]
Contains: 04719869701053
Package: [280 Units]
In Commercial Distribution
GS124719869701057 [Package]
Contains: 04719869701053
Package: [560 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-26

Devices Manufactured by TYSON BIORESEARCH INC.

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14719869702095 - Tyson Bio HS100-B Blood Glucose Monitoring System 2023-09-04
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14719869703221 - Tyson Bio HT100 Blood Glucose Monitoring System 2023-02-27
14719869703306 - Tyson Bio HT100-B Blood Glucose Monitoring System 2023-02-27
14719869704167 - Tyson Bio HT100-B Control Solution Level 32023-02-27
14719869704174 - Tyson Bio HT100-B Control Solution Level 22023-02-27
14719869704181 - Tyson Bio HT100-B Control Solution Level 12023-02-27

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