IMMUNO-TROL

Basic Information

• Brand Name: IMMUNO-TROL
• Primary DI: 03760170782096
• Version / Model: VASCULITIS
• Catalog Number: HM 067US-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: 1
• Public Version Date: 2018-10-25
• Public Version Status: New
• Public Device Record Key: dc8cab59-6155-42c6-a377-f2d520364916

Device Description

Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti- Myeloperoxidase MPO , anti- Proteinase 3 PR3 , anti-Glomerular Basal Membrane GBM .

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
54857	Multiple vasculitis-associated antibody IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen. These antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplamic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplamic antibodies to proteinase-3 (PR3).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760170782096	GS1

Customer Contacts

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

Storage Conditions

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