FIDIS MX 506

GUDID 03760170782003

Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes

THERADIAG SA

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex

• Primary Device ID: 03760170782003
• NIH Device Record Key: b671180f-0028-436c-a0a7-dbc9cd3dbedb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIDIS
• Version Model Number: Connective 10
• Catalog Number: MX 506
• Company DUNS: 391123478
• Company Name: THERADIAG SA
• 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: 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

Customer Support Contacts

• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com
• Phone: 0164621012
• Email: support@theradiag.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760170782003 [Primary]

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: 2022-03-08
• Device Publish Date: 2016-12-01

Devices Manufactured by THERADIAG SA

• 03760170782003 - FIDIS: 2022-03-08Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes
• 03760170782003 - FIDIS: 2022-03-08 Simultaneous detection kit of 10 antibodies: dsDNA, SSA 60, TRIM 21 (SSA 52), SSB, Sm, SmRNP, Scl70, Jo1, CENP-B, ribosomes
• 03760170782027 - IMMUNO-TROL: 2022-03-08 Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoan
• 03760170782034 - IMMUNO-TROL: 2022-03-08 Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoan
• 03760170782072 - IMMUNO-TROL: 2022-03-08 Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoan
• 03760170782102 - IMMUNO-TROL: 2021-06-08 Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoan