SAS One-Step Pregnancy

GUDID 00780311000196

SAS™ One-Step Pregnancy is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use only.

SA SCIENTIFIC, LTD.

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

• Primary Device ID: 00780311000196
• NIH Device Record Key: c5c7cd25-7ec8-444d-adfd-37ed9d038e7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAS One-Step Pregnancy
• 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	00780311000196 [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 One-Step Pregnancy]

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