ASI RPR Disposible Test Cards NC-9871010

GUDID 00816057021406

Detection of Syphilis, 300 - 10 well

ARLINGTON SCIENTIFIC, INC.

Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination

• Primary Device ID: 00816057021406
• NIH Device Record Key: c8e4207a-aa82-4bb9-8d62-fd94805231ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASI RPR Disposible Test Cards
• Version Model Number: NC-987010
• Catalog Number: NC-9871010
• 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: true
• 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@arlingtonscientific.com
• Phone: 801-489-8911
• Email: info@arlingtonscientific.com
• Phone: 801-489-8911
• Email: info@arlingtonscientific.com

Device Dimensions

• Area/Surface Area: 0.08 Square meter
• Area/Surface Area: 0.08 Square meter
• Area/Surface Area: 0.08 Square meter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816057021406 [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 Disposible Test Cards]

• 00816057021406: Detection of Syphilis, 300 - 10 well
• 00816057021390: Detection of Syphilis, 25 - 30, generic
• 00816057021376: Detection of Syphilis, 25 - 30 well
• 00816057021369: Detection of Syphilis, 25 - 15 well
• 00816057021352: Detection of Syphilis, 25 - 10 well, generic
• 00816057021345: Detection of Syphilis, 3000 - 10 well
• 00816057021338: Detection of Syphilis, 50 - 10 well
• 00816057021321: Detection of Syphilis, 25 - 10 well, generic