URiSCAN 10 SGL strip

GUDID 08806125680217

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

YD Diagnostics CORP.

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Primary Device ID08806125680217
NIH Device Record Key0ed128d8-fb49-47b6-8677-90cfeabef8ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameURiSCAN 10 SGL strip
Version Model NumberU774
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
GS108806125680217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

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 Date2016-12-21

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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