SAS One-Step Pregnancy

GUDID 00780311000202

SA SCIENTIFIC, LTD.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00780311000202
• NIH Device Record Key: 1f089fa4-b7b4-4b38-a590-e6eac99ca839
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAS One-Step Pregnancy
• Version Model Number: 087500
• 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	00780311000202 [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: 2018-11-01

On-Brand Devices [SAS One-Step Pregnancy]

• 00780311000202: 087500
• 00780311000196: SAS™ One-Step Pregnancy is a visual and rapid test for the qualitative determination of human