Specific IgE calibrator set

GUDID 00816879022087

HYCOR BIOMEDICAL LLC

Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator

• Primary Device ID: 00816879022087
• NIH Device Record Key: a0667139-6818-469d-b0b9-c694fe1c6ecd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Specific IgE calibrator set
• Version Model Number: 74119
• Company DUNS: 010558476
• Company Name: HYCOR BIOMEDICAL 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816879022087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941278

FDA Product Code

• DHB: System, Test, Radioallergosorbent (Rast) Immunological

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: 2016-09-26

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