FLC Lambda

Basic Information

• Brand Name: FLC Lambda
• Primary DI: 03607360051030
• Version / Model: 5103
• Catalog Number: 5103
• Company Name: SEBIA
• Labeler DUNS: 276801933
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-31
• Public Version: 1
• Public Version Date: 2023-04-10
• Public Version Status: New
• Public Device Record Key: 324d38c0-4c80-4eca-a6df-0ec519b4fd05

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
DEH	Lambda, Antigen, Antiserum, Control	Immunology	866.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53800	Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03607360051030	GS1

Premarket Submissions

Submission Number	Supplement Number
K210623	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: This way up Do not freeze Fragile-handle with care Keep dry