URiSCAN 10 SGL strip

GUDID 08806125680019

Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) and Leucocytes in urine.

YD Diagnostics CORP.

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Primary Device ID08806125680019
NIH Device Record Keybc6732bd-2ca4-480e-a34f-d9f11a3e12b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameURiSCAN 10 SGL strip
Version Model NumberU391
Company DUNS687769737
Company NameYD Diagnostics CORP.
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
GS108806125680019 [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 Number4
Public Version Date2021-12-22
Device Publish Date2016-08-05

On-Brand Devices [URiSCAN 10 SGL strip]

08806125680217Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Leucocytes, Nitri
08806125680019Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Bilirubin,

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