DIASTAT ANA FANA200

GUDID 07340058410486

Euro-Diagnostica AB

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07340058410486
• NIH Device Record Key: ef656cdc-af71-4739-894f-556fbe0ce455
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIASTAT ANA
• Version Model Number: FANA200
• Catalog Number: FANA200
• Company DUNS: 559894501
• Company Name: Euro-Diagnostica AB
• 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: true
• 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	07340058410486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932876

FDA Product Code

• LKJ: Antinuclear Antibody, Antigen, Control

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: 2016-08-12

Devices Manufactured by Euro-Diagnostica AB

• 07340058410004 - DIASTAT anti-Ro (SS-A): 2018-07-06
• 07340058410011 - DIASTAT anti-La (SS-B): 2018-07-06
• 07340058410035 - DIASTAT anti-dsDNA: 2018-07-06
• 07340058410059 - DIASTST anti-Sm: 2018-07-06
• 07340058410110 - DIASTAT anti-thyroglobulin: 2018-07-06
• 07340058410134 - DIASTAT anti-Thyroid Peroxidase: 2018-07-06
• 07340058410417 - DIASTAT anti-Mitochondrial: 2018-07-06
• 07340058410431 - CCPoint: 2018-07-06