SAS Legionella Test

GUDID 00780311000172

SA SCIENTIFIC, LTD.

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

• Primary Device ID: 00780311000172
• NIH Device Record Key: a814848e-c8c0-415b-8814-17cf1ee0fc4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAS Legionella Test
• Version Model Number: 044020-B
• 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	00780311000172 [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 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