AUTION™ Sticks 9EB Test Strips

GUDID 00015482736279

Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.

ARKRAY USA, INC.

Urine analyser IVD, laboratory

• Primary Device ID: 00015482736279
• NIH Device Record Key: 6dfc7a1d-ec29-4b75-acb3-fb0095f090d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTION™ Sticks 9EB Test Strips
• Version Model Number: 73627
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• Email: xxx@xxx.xxx
• Phone: +1(877)538-8872
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482736279 [Primary]
GS1	50015482736274 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093098

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: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2016-09-23

Devices Manufactured by ARKRAY USA, INC.

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• 00015482771010 - SPOTCHEM™ II Glucose: 2024-05-31 Strip description for the invitro quantitative determination of glucose in human plasma from whole blood samples
• 00015482771027 - SPOTCHEM™ II Uric Acid: 2024-05-31 Strip description for the invitro quantitative determination of uric acid concentration in human plasma from whole blood samples
• 00015482771034 - SPOTCHEM™ II Total Cholesterol: 2024-05-31 Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples
• 00015482771041 - SPOTCHEM™ II Triglycerides: 2024-05-31 Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples
• 00015482771058 - SPOTCHEM™ II BUN: 2024-05-31 Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples
• 00015482771065 - SPOTCHEM™ II Total Bilirubin: 2024-05-31 Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood s
• 00015482771072 - SPOTCHEM™ II Calcium: 2024-05-31 Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples