UCARE 11 Stick

GUDID 08806125680279

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

YD Diagnostics CORP.

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid
Primary Device ID08806125680279
NIH Device Record Key7def080a-0bcd-41e8-91c2-1b6cf7f44f58
Commercial Distribution StatusIn Commercial Distribution
Brand NameUCARE 11 Stick
Version Model NumberP411
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
GS108806125680279 [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 Date2017-07-28

On-Brand Devices [UCARE 11 Stick]

08806125680286Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Keto
08806125680279Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Keto

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