NOVEOS Elm, Ulmus americana 8633130

GUDID 00816879024043

HYCOR BIOMEDICAL LLC

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

• Primary Device ID: 00816879024043
• NIH Device Record Key: b03c75ea-04de-4f75-b4ca-c8d40fa28c4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVEOS Elm, Ulmus americana
• Version Model Number: T008
• Catalog Number: 8633130
• Company DUNS: 010558476
• Company Name: HYCOR BIOMEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00816879024043 [Primary]

FDA Product Code

• PUW: System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens

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: 2025-01-10
• Device Publish Date: 2025-01-02

Devices Manufactured by HYCOR BIOMEDICAL LLC

• 00816879024043 - NOVEOS Elm, Ulmus americana: 2025-01-10
• 00816879024043 - NOVEOS Elm, Ulmus americana: 2025-01-10
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• 00816879025194 - NOVEOS Wall Pellitory, Parietaria officinalis: 2024-10-29
• 00816879028300 - NOVEOS Sheep Sorrel, Rumex acetosella: 2024-10-29
• 00816879024166 - NOVEOS Russian Thistle, Salsola kali: 2024-10-07
• 00816879024906 - NOVEOS English Plantain, Plantago lanceolata: 2024-10-07
• 00816879028317 - NOVEOS Olive Tree, Olea europaea: 2024-10-07
• 00816879024067 - NOVEOS Cottonwood Tree, Populus deltoides: 2024-09-06