Tyson Bio 50H Control Solution (Level 1)

GUDID 04719869702357

TYSON BIORESEARCH INC.

Glucose IVD, control
Primary Device ID04719869702357
NIH Device Record Keyd8b6df0f-7981-446a-b7a6-3449947df4a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyson Bio 50H Control Solution (Level 1)
Version Model NumberTyson Bio 50H
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
GS104719869702357 [Primary]
GS114719869702354 [Package]
Package: [100 Units]
In Commercial Distribution
GS124719869702351 [Package]
Package: [1000 Units]
In Commercial Distribution
GS134719869702358 [Package]
Package: [20 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 Date2019-03-19
Device Publish Date2019-03-11

Devices Manufactured by TYSON BIORESEARCH INC.

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14719869702033 - Tyson Bio HS100 Blood Glucose Monitoring System 2023-09-04
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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