Performance Check Dye Kit GSD01-2450

GUDID B350GSD0124500

Performance Check Dye Kit

Gold Standard Diagnostics Corporation

Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: B350GSD0124500
• NIH Device Record Key: 10994c7a-cfeb-462d-adaa-a4b918b889ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Performance Check Dye Kit
• Version Model Number: GSD01-2450
• Catalog Number: GSD01-2450
• Company DUNS: 790524891
• Company Name: Gold Standard Diagnostics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B350GSD0124500 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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

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• 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: 2023-09-21 AIX1000 Performance Check Dye Kit
• B350GSD0124500 - Performance Check Dye Kit: 2023-09-21Performance Check Dye Kit
• B350GSD0124500 - Performance Check Dye Kit: 2023-09-21 Performance Check Dye Kit
• B350GSD051600NC0 - RPR Non-Reactive Control: 2023-09-21 RPR Non-Reactive Control