IMMUNO-TROL

Basic Information

• Brand Name: IMMUNO-TROL
• Primary DI: 03760170782058
• Version / Model: APS IgM
• Catalog Number: HM 063US-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: a4270e1f-a42a-481e-ad7e-4be6589f3e5e

Device Description

Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-Cardiolipin IgM isotype aCL IgM , anti-Phospholipides IgM Isotype aPL IgM , anti-Beta 2 - glycoprotein 1 IgM isotype β2GP1 IgM , anti-Prothrombin IgM isotype FII IgM .

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
41691	Phospholipid antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple antiphospholipid antibodies associated with antiphospholipid syndrome in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760170782058	GS1

Customer Contacts

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

Storage Conditions

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