Exploro Urinary Tract Infection (UTI) Test UTI-1

GUDID 06974246462967

Safecare Biotech (Hangzhou) Co., Ltd.

Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Primary Device ID06974246462967
NIH Device Record Keye919a8ed-614d-4723-8cd6-137bf2247186
Commercial Distribution StatusIn Commercial Distribution
Brand NameExploro Urinary Tract Infection (UTI) Test
Version Model Number5 tests
Catalog NumberUTI-1
Company DUNS544349634
Company NameSafecare Biotech (Hangzhou) Co., Ltd.
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106974246462967 [Primary]

FDA Product Code

LJXTest, Urine Leukocyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-17
Device Publish Date2026-03-09

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