Uri-Trak 120 M Urine Analyzer G1300-001

GUDID 00657498002094

The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

STANBIO LABORATORY, L.P.

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Primary Device ID00657498002094
NIH Device Record Key8f057c17-c18a-4bf1-a883-ca7ac1c6ba9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUri-Trak 120 M Urine Analyzer
Version Model NumberG1300-001
Catalog NumberG1300-001
Company DUNS045361136
Company NameSTANBIO LABORATORY, L.P.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com
Phone18005315535
Emailinfo@ekfdiagnostics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100657498002094 [Primary]

FDA Product Code

JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

Devices Manufactured by STANBIO LABORATORY, L.P.

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00657498002094 - Uri-Trak 120 M Urine Analyzer2023-06-16 The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for th
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00657498002346 - HGB Controls - Normal2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
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00657498002360 - HGB Controls - High2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
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00657498001806 - Standard 12020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy

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