NOVEOS IgE Calibrator Set

GUDID 00816879023251

HYCOR BIOMEDICAL LLC

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00816879023251
• NIH Device Record Key: 3e8b1d2d-2523-4309-b853-6e3672e05ffa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVEOS IgE Calibrator Set
• Version Model Number: 63125
• 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: 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: 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
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816879023251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182479

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-20
• Device Publish Date: 2025-05-12

On-Brand Devices [NOVEOS IgE Calibrator Set]

• 00816879023015: 63145
• 00816879029499: 63125Z
• 00816879023251: 63125