K-ASSAY® IgM Reagent

Basic Information

• Brand Name: K-ASSAY® IgM Reagent
• Primary DI: 00816426020115
• Version / Model: KAI-015
• Catalog Number: KAI-015
• Company Name: KAMIYA BIOMEDICAL COMPANY, LLC
• Labeler DUNS: 197934250
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7360343f-556f-4511-9568-9e4c1abc998b

Device Description

For the quantitative determination of human IgM in serum by immunoturbidimetric assay.

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
CFF	Immunoelectrophoretic, Immunoglobulins, (G, A, M)	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53794	Total immunoglobulin M (IgM total) 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 total immunoglobulin M (IgM total) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816426020115	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K993323	000

Storage Conditions

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