ASI RPR Automated Control Set NC905005A

GUDID 00816057021703

RPR Control Set for use on the ASI Evolution Analyzer. 5.0 ml each of reactive, weak reactive and nonreactive controls

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination

• Primary Device ID: 00816057021703
• NIH Device Record Key: e5f306b7-a282-4aec-914b-4016b2833dec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASI RPR Automated Control Set
• Version Model Number: NC-905005A
• Catalog Number: NC905005A
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816057021703 [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 Automated Control Set ]

• 00816057021703: RPR Control Set for use on the ASI Evolution Analyzer. 5.0 ml each of reactive, weak reactive a
• 00816057021697: RPR Control Set for use on the ASI Evolution Analyzer. 2.5 ml each of reactive, weak reactive a