ASI Evolution NC-2800-000

GUDID 00816057021666

Automated RPR Analyzer.

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination

• Primary Device ID: 00816057021666
• NIH Device Record Key: fe25911b-ded4-4e19-b1a6-1f29fa068339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASI Evolution
• Version Model Number: NC-2800-000
• Catalog Number: NC-2800-000
• Company DUNS: 785966607
• Company Name: ARLINGTON SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: true
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816057021666 [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

Devices Manufactured by ARLINGTON SCIENTIFIC, INC.

• 00816057021666 - ASI Evolution: 2023-12-27Automated RPR Analyzer.
• 00816057021666 - ASI Evolution: 2023-12-27 Automated RPR Analyzer.
• 00816057021673 - ASI RPR Test for Syphilis for Use on the ASI Evolution: 2023-12-27 Syphilis Screening Test for Use on the ASI Evolution analyzer. 480 test kit
• 00816057021680 - ASI RPR Test for Syphilis for Use on the ASI Evolution: 2023-12-27 Syphilis Screening Test for Use on the ASI Evolution Analyzer. 4800 test kit
• 00816057021697 - ASI RPR Automated Control Set: 2023-12-27 RPR Control Set for use on the ASI Evolution Analyzer. 2.5 ml each of reactive, weak reactive and nonreactive controls.
• 00816057021703 - ASI RPR Automated Control Set: 2023-12-27 RPR Control Set for use on the ASI Evolution Analyzer. 5.0 ml each of reactive, weak reactive and nonreactive controls
• 00816057021710 - ASI Evolution RPR Titration Diluent: 2023-12-27 RPR Sample Diluent used on the ASI Evolution Analyzer for performing sample titrations. 25 ml
• 00816057021796 - ASI RPR Card Test for Syphilis: 2023-12-27 Syphilis Screening Test with reactive and nonreactive controls. 100 test kit
• 00816057021802 - ASI RPR Card Test for Syphilis: 2023-12-27 Syphilis Screening Test with reactive and nonreactive controls. 500 test kit