IMMUNO-TROL HM 060US-2X05

GUDID 03760170782027

Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid– Level 1 DNA* , Anti-Sjögren’s Syndrom antigen A - 60 kDa. SS-A 60, Anti-Sjögren’s Syndrom antigen A - 52 kDa SS-A 52 , Anti-Sjögren’s Syndrom antigen B SS-B, Anti-Smith antigen Sm , Anti-Smith and ribonucleoproteins antigens Sm/RNP , Anti- U1 ribonucleoproteins antigen U1RNP .

THERADIAG SA

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

• Primary Device ID: 03760170782027
• NIH Device Record Key: 7666a7a1-d441-43c2-9e8d-508e1b264bcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMMUNO-TROL
• Version Model Number: CONNECTIVE 1
• Catalog Number: HM 060US-2X05
• Company DUNS: 391123478
• Company Name: THERADIAG SA
• 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: 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	03760170782027 [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: 2
• Public Version Date: 2022-03-08
• Device Publish Date: 2018-09-24

On-Brand Devices [IMMUNO-TROL]

• 03760170782102: Reagent, prepared from human serum, intended for use as an unassayed precision control for deter
• 03760170782072: Reagent, prepared from human serum, intended for use as an unassayed precision control for deter
• 03760170782034: Reagent, prepared from human serum, intended for use as an unassayed precision control for deter
• 03760170782027: Reagent, prepared from human serum, intended for use as an unassayed precision control for deter