GUDID 00848838065262

REMEL, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination

• Primary Device ID: 00848838065262
• NIH Device Record Key: ab8eb419-11a4-4da3-87f8-d7f22307bf67
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: R2468936
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• Device Count: 24
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com
• Phone: 8002556730
• Email: ITechnicalSupport@remel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838065262 [Primary]
GS1	00848838099793 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881247

FDA Product Code

• KTN: System, Test, Infectious Mononucleosis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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