TysonBio AC500 Blood Glucose Test Strips, 10T

GUDID 04719869703132

TYSON BIORESEARCH INC.

Glucose IVD, kit, electrometry
Primary Device ID04719869703132
NIH Device Record Key9cd3f2b0-df74-47e8-bbe4-cc1aab0ba291
Commercial Distribution StatusIn Commercial Distribution
Brand NameTysonBio AC500 Blood Glucose Test Strips, 10T
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
GS104719869703132 [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 Date2020-04-23
Device Publish Date2020-04-15

Devices Manufactured by TYSON BIORESEARCH INC.

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