GUDID 00848838091834

REMEL, INC.

Anti-tuberculosis (anti-TB) drug susceptibility testing reagent kit IVD

• Primary Device ID: 00848838091834
• NIH Device Record Key: d2982896-85ce-4b54-85fd-57745063a235
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 7116-70
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848838091834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052323

FDA Product Code

• MJA: Susceptibility Test Powders, Antimycobacterial

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-09

Devices Manufactured by REMEL, INC.

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• 00848838007736 - REMEL: 2024-11-07 Lysozyme Broth (5ml) 20/PK
• 00842558116419 - ACT I Transport PK/10: 2024-08-14
• 00842558116426 - ACT II Transport PK/10: 2024-08-14
• 00842558116433 - ACT II Dual Transport PK/10: 2024-08-14
• 05032384519903 - ProSpecT: 2024-08-06 ProSpecT C. diff Toxin A/B MP KT/96TST
• 00848838002724 - REMEL: 2024-05-14 Pseudomonas P Agar 10/PK