N FLC Standard SL

Basic Information

• Brand Name: N FLC Standard SL
• Primary DI: 00842768031441
• Version / Model: 10482440
• Catalog Number: OPJD03
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2018-02-20
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 7600d7c2-38cd-46eb-89d1-e316abf7498f

Device Description

Establishment of reference curves for the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
DFH	KAPPA, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41430	Kappa/lambda light chain immunoglobulin IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768031441	GS1
Unit of Use	04056869221946	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171742	000

Storage Conditions

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