Tyson Bio HT100-B Control Solution Level 2

GUDID 14719869704174

TYSON BIORESEARCH INC.

Glucose IVD, control
Primary Device ID14719869704174
NIH Device Record Keyd3cd8df0-d24b-49e5-bbe6-77c112eac520
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyson Bio HT100-B Control Solution Level 2
Version Model NumberHT100-B
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
GS104719869704177 [Primary]
GS114719869704174 [Package]
Contains: 04719869704177
Package: [50 Units]
In Commercial Distribution
GS124719869704171 [Package]
Contains: 04719869704177
Package: [1000 Units]
In Commercial Distribution
GS134719869704178 [Package]
Contains: 04719869704177
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 Date2023-02-27
Device Publish Date2023-02-17

Devices Manufactured by TYSON BIORESEARCH INC.

14719869705881 - Tyson Bio HS100 Blood Glucose Test Strips2024-11-19
04719869705891 - Tyson Bio HS100 Blood Glucose Test Strips2024-11-19
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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