Lucidplus B-Ketone Test Strips 50 count

GUDID 00851225008025

VIDAN DIAGNOSTICS LLC

Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent
Primary Device ID00851225008025
NIH Device Record Key2d475d8f-835a-4e44-8582-54401dfe7c50
Commercial Distribution StatusIn Commercial Distribution
Brand NameLucidplus B-Ketone Test Strips 50 count
Version Model Number3100-050
Company DUNS092729952
Company NameVIDAN DIAGNOSTICS LLC
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
GS100851225008025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-07
Device Publish Date2018-12-06

Devices Manufactured by VIDAN DIAGNOSTICS LLC

00851225008001 - LucidPlus B-Ketone Plus Blood Glucose Monitoring System 2019-12-11
00851225008025 - Lucidplus B-Ketone Test Strips 50 count2019-01-07
00851225008025 - Lucidplus B-Ketone Test Strips 50 count2019-01-07
00851225008032 - Lucidplus Glucose Test strips 50 count2019-01-04
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