ASI RPR Test for Syphilis for Use on the ASI Evolution NC-9004800ABB

GUDID 00816057021680

Syphilis Screening Test for Use on the ASI Evolution Analyzer. 4800 test kit

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination

• Primary Device ID: 00816057021680
• NIH Device Record Key: 0d358595-252c-4814-bcdf-90848e964e8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASI RPR Test for Syphilis for Use on the ASI Evolution
• Version Model Number: NC-9004800ABB
• Catalog Number: NC-9004800ABB
• Company DUNS: 785966607
• Company Name: ARLINGTON SCIENTIFIC, 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: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816057021680 [Primary]

FDA Product Code

• GMQ: Antigens, Nontreponemal, All

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: 2023-12-27
• Device Publish Date: 2023-12-19

On-Brand Devices [ASI RPR Test for Syphilis for Use on the ASI Evolution]

• 00816057021680: Syphilis Screening Test for Use on the ASI Evolution Analyzer. 4800 test kit
• 00816057021673: Syphilis Screening Test for Use on the ASI Evolution analyzer. 480 test kit