Sure-Vue hCG Urine Control set

GUDID 00780311000615

SA SCIENTIFIC, LTD.

Total human chorionic gonadotropin (HCG) IVD, control

• Primary Device ID: 00780311000615
• NIH Device Record Key: 352ed2c1-475f-4aef-ab30-46b1230a9c00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-Vue hCG Urine Control set
• Version Model Number: 087413
• 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	00780311000615 [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.

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• 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
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• 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