IMMUNO-TROL

Basic Information

• Brand Name: IMMUNO-TROL
• Primary DI: 03760170782034
• Version / Model: CONNECTIVE 2
• Catalog Number: HM 061US-2X05
• Company Name: THERADIAG SA
• Labeler DUNS: 391123478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2022-03-08
• Public Version Status: Update
• Public Device Record Key: e3590496-d50d-4c84-b9e7-f717ee893072

Device Description

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 2 DNA* , Anti-ribosomal antigen Ribo , Anti-centromere antigen CENP-B , Anti-histidyl tRNA synthetase antigen Jo-1 , Anti-scleroderma antigen - 70 kDA Scl-70 .

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
46080	Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening for multiple types of antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760170782034	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius