Urine Reagent Strips, 1-parameter, glucose

GUDID 00664816000069

Urine reagent strips; 1-parameter; glucose; 100 strips per vial

LW SCIENTIFIC, INC.

Urine glucose IVD, kit, colorimetric dipstick, rapid
Primary Device ID00664816000069
NIH Device Record Keyb59e7d8c-40df-4ff1-bf84-0c8445854825
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrine Reagent Strips, 1-parameter, glucose
Version Model NumberURS-01PR-GL77
Company DUNS785335381
Company NameLW SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100664816000069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

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