Leishmania infantum IgG Level 1 Serum GSD01-3006-L1

GUDID B350GSD013006L10

Leishmania infantum IgG Level 1 Serum

Gold Standard Diagnostics Corporation

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD

• Primary Device ID: B350GSD013006L10
• NIH Device Record Key: 4525e1ad-3c67-44fd-a494-89a9a5b4ef32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leishmania infantum IgG Level 1 Serum
• Version Model Number: GSD01-3006-L1
• Catalog Number: GSD01-3006-L1
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B350GSD013006L10 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2023-03-23
• Device Publish Date: 2023-03-15

Devices Manufactured by Gold Standard Diagnostics Corporation

• 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: 2023-09-21 AIX1000 Performance 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