Sure-Vue Adeno Test

GUDID 00780311000509

Sure-Vue® Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.

SA SCIENTIFIC, LTD.

Adenovirus antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00780311000509
• NIH Device Record Key: aa20cce2-50c4-46c7-b7bd-bb3eefbd98c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-Vue Adeno Test
• Version Model Number: 067020
• 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	00780311000509 [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

Devices Manufactured by SA SCIENTIFIC, LTD.

• 00780311000882 - CliaWaived Rapid Strep A Test: 2019-02-28
• 00780311000011 - SAS Pregnancy Serum/Urine: 2018-12-03 SAS™ Pregnancy Serum/Urine is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG)
• 00780311000035 - SAS Adenovirus Controls: 2018-12-03 SAS™ Adenovirus Controls are controls for use with SAS™ Adenovirus test kits. These controls are for professional use only.
• 00780311000066 - SAS ASO-Latex: 2018-12-03 SAS™ ASO-Latex is a rapid latex agglutination test for the qualitative and semi-quantitative determination of Antistreptolysim
• 00780311000073 - SAS ASO-Latex: 2018-12-03
• 00780311000080 - SAS CRP-Latex: 2018-12-03 The SAS™ CRP-Latex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of C-React
• 00780311000103 - SAS hCG Serum Control Set: 2018-12-03 SAS™ hCG Serum Controls are intended to be used to monitor the performance and accuracy of SAS™ Serum/Urine hCG pregnancy te
• 00780311000134 - SAS Herpes Check Test: 2018-12-03 SAS Herpes Check lateral flow test kit is a visual and rapid assay for the qualitative detection of Herpes Simplex Virus Types 1