ProSpecT R244596

GUDID 05032384519903

ProSpecT C. diff Toxin A/B MP KT/96TST

REMEL, INC.

Bacterial species differentiation disc IVD

• Primary Device ID: 05032384519903
• NIH Device Record Key: 0fc963b4-5202-4fd3-af19-0c92dfdd6d9d
• Commercial Distribution Discontinuation: 2024-08-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ProSpecT
• Version Model Number: R244596
• Catalog Number: R244596
• Company DUNS: 065769564
• Company Name: REMEL, INC.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384519903 [Primary]

FDA Product Code

• LLH: Reagents, Clostridium Difficile Toxin

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: 2024-08-06
• Device Publish Date: 2022-12-23

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