AUTION™ Sticks 9EB - Test Strips

GUDID 00015482117344

AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders.

ARKRAY USA, INC.

Urine analyser IVD, laboratory

• Primary Device ID: 00015482117344
• NIH Device Record Key: e10b9737-8f6a-4f7d-9746-c39cb3126a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTION™ Sticks 9EB - Test Strips
• Version Model Number: 110734
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx
• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482117344 [Primary]
GS1	50015482117349 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193514

FDA Product Code

• KQO: Automated Urinalysis System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-10
• Device Publish Date: 2024-12-02

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• 00015482117313 - AUTION MAX™ AX-4060 Analyzer: 2024-12-10 The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis sytem intend
• 00015482117344 - AUTION™ Sticks 9EB - Test Strips: 2024-12-10AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders.
• 00015482117344 - AUTION™ Sticks 9EB - Test Strips: 2024-12-10 AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following ana