RAPIDEC® CARBA NP

GUDID 03573026464387

RAPIDEC® CARBA NP is a phenotypic test for rapid detection and confirmation of carbapenemase enzyme presence in Enterobacteriaceae and Pseudomonas aeruginosa isolated colonies

BIOMERIEUX SA

Multiple bacteria carbapenemase production IVD, kit, chromogenic

• Primary Device ID: 03573026464387
• NIH Device Record Key: 17bc9be5-a138-4c3e-8dfe-8a4218a5824c
• Commercial Distribution Discontinuation: 2018-12-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RAPIDEC® CARBA NP
• Version Model Number: RAPIDEC® CARBA NP
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026464387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162385

FDA Product Code

• PTJ: Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-01
• Device Publish Date: 2017-07-04

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