K-ASSAY® IgM Reagent KAI-015

GUDID 00816426020115

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

KAMIYA BIOMEDICAL COMPANY, LLC

Total immunoglobulin M (IgM total) IVD, reagent Total immunoglobulin M (IgM total) IVD, reagent Total immunoglobulin M (IgM total) IVD, reagent

• Primary Device ID: 00816426020115
• NIH Device Record Key: 7360343f-556f-4511-9568-9e4c1abc998b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-ASSAY® IgM Reagent
• Version Model Number: KAI-015
• Catalog Number: KAI-015
• Company DUNS: 197934250
• Company Name: KAMIYA BIOMEDICAL COMPANY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 206-575-8068
• Email: diagnostics@k-assay.com
• Phone: 206-575-8068
• Email: diagnostics@k-assay.com
• Phone: 206-575-8068
• Email: diagnostics@k-assay.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816426020115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993323

FDA Product Code

• CFF: Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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