Uri-Trak 120 Analyzer G1200-001

GUDID 00657498000076

The Uri-Trak™ 120 Urine Analyzer is intended for use in conjunction with Stanbio Uri-Chek™ and Uri-Con™ 10 Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only.

STANBIO LABORATORY, L.P.

Urine analyser IVD, laboratory, automated Urine analyser IVD, laboratory, automated Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory

• Primary Device ID: 00657498000076
• NIH Device Record Key: 56f1233d-5533-43cc-becd-f556cab6f05d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uri-Trak 120 Analyzer
• Version Model Number: G1200-001
• Catalog Number: G1200-001
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498000076 [Primary]

FDA Product Code

• KQO: Automated Urinalysis System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by STANBIO LABORATORY, L.P.

• 00657498002094 - Uri-Trak 120 M Urine Analyzer: 2023-06-16 The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for th
• 00657498002322 - HGB Controls - Low: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002339 - HGB Controls - Low: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002346 - HGB Controls - Normal: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002353 - HGB Controls - Normal: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002360 - HGB Controls - High: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498002377 - HGB Controls - High: 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
• 00657498001806 - Standard 1: 2020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy