N Supplementary Reagent L

Basic Information

• Brand Name: N Supplementary Reagent L
• Primary DI: 00842768008061
• Version / Model: 10446128
• Catalog Number: OQTD11
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 42257505-7c72-4831-8a7e-9fb25e2058b7

Device Description

Supplementary reagent for multiple protein assays on BN Systems

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
DDG	TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43805	Immunoglobulin removal reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs for the removal, adsorption, absorption, or inactivation of non-specific immunoglobulins and/or rheumatoid factor antibodies present in a clinical specimen, to prevent interference when testing for other specific classes of immunoglobulin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768008061	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K991157	000

Storage Conditions

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