AIX1000 Performance Check Dye Kit GSD01-1600-DYE

GUDID B350GSD011600DYE0

AIX1000 Performance Check Dye Kit

Gold Standard Diagnostics Corporation

Treponema pallidum reagin antibody IVD, kit, agglutination

• Primary Device ID: B350GSD011600DYE0
• NIH Device Record Key: 355c6891-08e2-4219-adf0-c43cfdddb994
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIX1000 Performance Check Dye Kit
• Version Model Number: GSD01-1600-DYE
• Catalog Number: GSD01-1600-DYE
• Company DUNS: 790524891
• Company Name: Gold Standard Diagnostics Corporation
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B350GSD011600DYE0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-21
• Device Publish Date: 2023-09-13

Devices Manufactured by Gold Standard Diagnostics Corporation

• B350GSD0116005C0 - Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C: 2024-12-16 Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C
• B350GSD051600MW0 - Microtiterplates (5): 2024-10-30 Microtiterplates (5)
• B35000300CLR0 - ThunderBolt EIA (CLIA): 2023-11-08 ThunderBolt EIA-CLIA (refurbished)
• B35000300R0 - ThunderBolt EIA: 2023-11-08 ThunderBolt EIA (refurbished)
• B35000400R0 - AIX1000 Analyzer: 2023-11-08 AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished)
• B35000500CLR0 - Bolt (CLIA): 2023-11-08 Bolt EIA-CLIA (refurbished)
• B35000500R0 - Bolt: 2023-11-08 Bolt EIA (refurbished)
• B350GSD011600DYE0 - AIX1000 Performance Check Dye Kit: 2023-09-21AIX1000 Performance Check Dye Kit
• B350GSD011600DYE0 - AIX1000 Performance Check Dye Kit: 2023-09-21 AIX1000 Performance Check Dye Kit