TysonBio AC500 Blood Glucose Test Strips, 25T

GUDID 14719869703122

TYSON BIORESEARCH INC.

Glucose IVD, kit, electrometry
Primary Device ID14719869703122
NIH Device Record Key8394f2dc-1176-4d06-8851-8437a4517991
Commercial Distribution StatusIn Commercial Distribution
Brand NameTysonBio AC500 Blood Glucose Test Strips, 25T
Version Model NumberAC500
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS104719869703125 [Primary]
GS114719869703122 [Package]
Contains: 04719869703125
Package: [280 Units]
In Commercial Distribution
GS124719869703129 [Package]
Contains: 04719869703125
Package: [560 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-23
Device Publish Date2020-04-15

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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