Urine Reagent Strips, 1-parameter, blood

GUDID 00664816000076

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

LW SCIENTIFIC, INC.

Urine blood IVD, kit, colorimetric, rapid
Primary Device ID00664816000076
NIH Device Record Key8c676b34-cd67-403d-a578-0f0b3ec240b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrine Reagent Strips, 1-parameter, blood
Version Model NumberURS-01PR-BL77
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100664816000076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIOBlood, Occult, Colorimetric, In Urine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2016-09-19

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00664816001431 - LW Scientific, Inc.2023-09-18 Water Bath - circulating, variable temp, 20 liter, 110V
00664816001592 - LW Scientific, Inc.2023-09-18 Water Bath - circulating, variable temp, 10 liter, 110V
00664816003824 - LW Scientific, Inc.2023-09-18 Water Bath - circulating, variable temp, 10 liter, 220V
00664816003831 - LW Scientific, Inc.2023-09-18 Water Bath - circulating, variable temp, 20 liter, 220V
00664816001943 - LW Scientific, Inc.2023-07-05 Epi-illumination module - LED 485nm excite, 510nm barrier, for Mi5 Epi microscope

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