NOVEOS House Dust - Greer 8633810

GUDID 00816879025026

HYCOR BIOMEDICAL LLC

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

• Primary Device ID: 00816879025026
• NIH Device Record Key: 3d3b8d70-b275-4b26-bf46-282d7eb52162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVEOS House Dust - Greer
• Version Model Number: H001
• Catalog Number: 8633810
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816879025026 [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: 2025-07-03
• Device Publish Date: 2025-06-25

Devices Manufactured by HYCOR BIOMEDICAL LLC

• 00816879025026 - NOVEOS House Dust - Greer: 2025-07-03
• 00816879025026 - NOVEOS House Dust - Greer: 2025-07-03
• 00816879023916 - NOVEOS Sweet Vernal Grass, Anthoxanthum odoratum: 2025-06-09
• 00816879023251 - NOVEOS IgE Calibrator Set: 2025-05-20
• 00816879023534 - NOVEOS Egg White, Gallus gallus: 2025-05-20
• 00816879023541 - NOVEOS Cow's Milk, Bos taurus: 2025-05-20
• 00816879023626 - NOVEOS Alternaria alternata: 2025-05-20
• 00816879023633 - NOVEOS Oak, Quercus alba: 2025-05-20
• 00816879023671 - NOVEOS Common Silver Birch, Betula verrucosa: 2025-05-20