InstaTest URS-1P(100)

GUDID 00850049545921

InstaTest URS-1P is intended semi-quantitative and qualitative detection of protein in urine.

Diagnostic Automation, Inc.

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 00850049545921
• NIH Device Record Key: 10b92d80-ffff-4a42-aac5-75ec49eca416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaTest
• Version Model Number: DACDURS-1P (100)
• Catalog Number: URS-1P(100)
• Company DUNS: 878252071
• Company Name: Diagnostic Automation, Inc.
• 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: true
• 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: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com
• Phone: 818-591-3030
• Email: Onestep@rapidtest.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850049545921 [Primary]

FDA Product Code

• JIR: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

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: 2023-06-22
• Device Publish Date: 2023-06-14

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