AIX1000 Analyzer

GUDID B350004000

AIX1000 Rapid Plasma Reagin (RPR) Analyzer

GOLD STANDARD DIAGNOSTICS CORP.

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• Primary Device ID: B350004000
• NIH Device Record Key: 8dc581b9-91f9-484d-9731-e4bdc3ab8a8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIX1000 Analyzer
• Version Model Number: 00400
• Company DUNS: 790524891
• Company Name: GOLD STANDARD DIAGNOSTICS CORP.
• 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: false
• Device Combination Product: false
• Single Use: false
• 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
HIBCC	B350004000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150358

FDA Product Code

• GMQ: Antigens, Nontreponemal, All

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-29

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