NOVEOS Lamb’s Quarters, Goosefoot, Chenopodium album 8633340

GUDID 00816879024159

HYCOR BIOMEDICAL LLC

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

• Primary Device ID: 00816879024159
• NIH Device Record Key: d0a6e668-cfce-4c6e-a0a1-160a5f630dbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVEOS Lamb’s Quarters, Goosefoot, Chenopodium album
• Version Model Number: W010
• Catalog Number: 8633340
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816879024159 [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: 2025-09-02
• Device Publish Date: 2025-08-25

Devices Manufactured by HYCOR BIOMEDICAL LLC

• 00810053950623 - NOVEOS Lamb's Quarters, Goosefoot, Chenopodium album: 2025-09-02
• 00816879024159 - NOVEOS Lamb’s Quarters, Goosefoot, Chenopodium album: 2025-09-02
• 00816879024159 - NOVEOS Lamb’s Quarters, Goosefoot, Chenopodium album: 2025-09-02
• 00810053950180 - NOVEOS Carrot, Daucus carota: 2025-08-29
• 00816879024630 - NOVEOS Carrot, Daucus carota: 2025-08-29
• 00816879029956 - NOVEOS Sweet Vernal Grass, Anthoxanthum odoratum: 2025-07-08
• 00816879029963 - NOVEOS House Dust - Greer: 2025-07-08
• 00816879025026 - NOVEOS House Dust - Greer: 2025-07-03
• 00816879023916 - NOVEOS Sweet Vernal Grass, Anthoxanthum odoratum: 2025-06-09