AUTION™ Uriflet 9HA Test Strips

GUDID 04987486735212

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

ARKRAY USA, INC.

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• Primary Device ID: 04987486735212
• NIH Device Record Key: 8c54dfe3-52b3-494b-95fa-3280616f62b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTION™ Uriflet 9HA Test Strips
• Version Model Number: 73521
• 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(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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987486735212 [Primary]
GS1	54987486735217 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121456

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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