Syphilis Health Check

GUDID 00868926000302

VEDALAB

Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00868926000302
• NIH Device Record Key: c6700618-1a5c-4679-a788-465260237cfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syphilis Health Check
• Version Model Number: B012
• Company DUNS: 770675080
• Company Name: VEDALAB
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868926000302 [Primary]

FDA Product Code

• LIP: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-05-19

Devices Manufactured by VEDALAB

• 00868926000326 - Evidence Pregnancy Test: 2018-07-06
• 00868926000302 - Syphilis Health Check: 2018-03-29
• 00868926000302 - Syphilis Health Check: 2018-03-29