TysonBio AC500 Control Solution (Level 1)

GUDID 14719869703146

TYSON BIORESEARCH INC.

Glucose IVD, control
Primary Device ID14719869703146
NIH Device Record Key5c9899d2-6f74-4291-b7de-d0fd0b458b8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTysonBio AC500 Control Solution (Level 1)
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
GS104719869703149 [Primary]
GS114719869703146 [Package]
Contains: 04719869703149
Package: [100 Units]
In Commercial Distribution
GS124719869703143 [Package]
Contains: 04719869703149
Package: [1000 Units]
In Commercial Distribution
GS134719869703140 [Package]
Contains: 04719869703149
Package: [20 Units]
Discontinued: 2022-04-07
Not 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
04719869705396 - Tyson Bio HT100 Blood Glucose Meter2023-08-15
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

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