SAS RPR Kit

GUDID 00780311000325

Syphilis screening test.

SA SCIENTIFIC, LTD.

Treponema pallidum reagin antibody IVD, kit, agglutination

• Primary Device ID: 00780311000325
• NIH Device Record Key: 0b11b2dc-346c-48da-aa4e-4f5b4f254f6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAS RPR Kit
• Version Model Number: 087430
• Company DUNS: 122092117
• Company Name: SA SCIENTIFIC, LTD.
• 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: 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	00780311000325 [Primary]

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: 2018-12-03
• Device Publish Date: 2018-11-02

On-Brand Devices [SAS RPR Kit]

• 00780311000349: 084500
• 00780311000332: 084100
• 00780311000325: Syphilis screening test.