Accustrip Urine Reagent Strip Reader

GUDID 10763924850508

Urine Reagent Strip Reader For Use With Accustrip URS 10 Urine Reagent Strips. *CLIA-Waived*

JANT PHARMACAL CORPORATION

Urine catalase IVD, kit, rapid colorimetric, clinical
Primary Device ID10763924850508
NIH Device Record Keybac178ab-4ffe-45d7-9c03-71781bdbdd64
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccustrip Urine Reagent Strip Reader
Version Model NumberUA850
Company DUNS797393659
Company NameJANT PHARMACAL 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110763924850508 [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 Date2022-11-28
Device Publish Date2016-09-24

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