SAS Legionella Test

GUDID 00780311000844

The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires’ disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.

SA SCIENTIFIC, LTD.

Legionella pneumophila antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00780311000844
• NIH Device Record Key: f6105837-8811-4995-a56b-e0c6cefb121d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAS Legionella Test
• Version Model Number: 350080
• 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	00780311000844 [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 Legionella Test]

• 00780311000844: The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for th
• 00780311000189: 044020-M
• 00780311000172: 044020-B
• 00780311000165: The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for th