ASI RPR Dispensing Bottle NC-909002

GUDID 00816057021253

Detection of Syphilis

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination

• Primary Device ID: 00816057021253
• NIH Device Record Key: b131d979-9eff-487a-88a5-57498e12ff18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASI RPR Dispensing Bottle
• Version Model Number: NC-909002
• Catalog Number: NC-909002
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 801-489-8911
• Email: info@arlinigtonscientific.com
• Phone: 801-489-8911
• Email: info@arlinigtonscientific.com
• Phone: 801-489-8911
• Email: info@arlinigtonscientific.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temp

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816057021253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851504

FDA Product Code

• GMP: Antisera, Control For Nontreponemal Tests

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: 2016-07-08

On-Brand Devices [ASI RPR Dispensing Bottle]

• 00816057021253: Detection of Syphilis
• 00816057021246: Detection of Syphilis