Hytec 74407

GUDID 00816879022865

HYCOR BIOMEDICAL LLC

Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

• Primary Device ID: 00816879022865
• NIH Device Record Key: b32a87f3-d4eb-44bd-a7b7-619ac496cbbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hytec
• Version Model Number: Maple/Box Elder
• Catalog Number: 74407
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816879022865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821451

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: 2020-05-18
• Device Publish Date: 2020-05-08

On-Brand Devices [Hytec]

• 00816879022865: Maple/Box Elder
• 00816879022858: MCS Specific Total IgE Conjugate
• 00816879022841: Specific IgE Reference Disc