IMMULITE 2000 rMal d 1 Specific Allergen

Basic Information

• Brand Name: IMMULITE 2000 rMal d 1 Specific Allergen
• Primary DI: 00630414006246
• Version / Model: 10483381
• Catalog Number: A464L2
• 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: 2022-09-12
• Public Version: 1
• Public Version Date: 2022-09-20
• Public Version Status: New
• Public Device Record Key: cf40230d-2ef4-4a02-b6e4-12d6d4b79c71

Device Description

rMal d 1 Allergen

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
53782	Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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	00630414006246	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132801	000

Storage Conditions

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