TysonBio AC200 Blood Glucose Test Strip, 10T

GUDID 04719869702395

TYSON BIORESEARCH INC.

Glucose IVD, kit, electrometry
Primary Device ID04719869702395
NIH Device Record Key4250e41c-d310-4a13-b668-c9e9ca3c085b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTysonBio AC200 Blood Glucose Test Strip, 10T
Version Model NumberTysonBio AC200
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
GS104719869702395 [Primary]

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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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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