IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2

Basic Information

• Brand Name: IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2
• Primary DI: 00630414984575
• Version / Model: 10485105
• Catalog Number: DC2LCM
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• Labeler DUNS: 296822794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 3349131e-ac44-4145-8a85-abbb61ed11e7

Device Description

Specific IgE D2 - IMMULITE - CTL - 1x4mL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DHB	SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL	Immunology	866.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41349	Allergen-specific immunoglobulin E (IgE) 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 immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414984575	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013134	000

Storage Conditions

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