Areta 10 Parameters Urinalysis Reagent Strips (50 tests kit)

GUDID 00850253007048

EASY HEALTHCARE CORPORATION

Multiple urine analyte IVD, control
Primary Device ID00850253007048
NIH Device Record Key050f7cc9-8c50-422c-956b-4d870808f8e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreta 10 Parameters Urinalysis Reagent Strips (50 tests kit)
Version Model NumberU031-103
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850253007048 [Primary]
GS100850253007055 [Package]
Package: [1 Units]
In Commercial Distribution
GS110850253007052 [Package]
Contains: 00850253007055
Package: [180 Units]
In Commercial Distribution

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 Date2019-07-22
Device Publish Date2016-08-05

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