ePlex KT022279

GUDID 00857167005283

ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch

GENMARK DIAGNOSTICS, INC.

Multiple Candida/yeast species culture isolate identification IVD, kit

• Primary Device ID: 00857167005283
• NIH Device Record Key: be261bcc-e804-4f21-96b9-bca7a727d93d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ePlex
• Version Model Number: BCID_FP Cartridge Pouch
• Catalog Number: KT022279
• Company DUNS: 962104217
• Company Name: GENMARK DIAGNOSTICS, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857167005283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182690

FDA Product Code

• PEO: Fungal Organisms, Nucleic Acid-Based Assay

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: 2019-08-30
• Device Publish Date: 2019-08-22

On-Brand Devices [ePlex]

• 00857167005337: ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch
• 00857167005320: ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box
• 00857167005313: ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box
• 00857167005306: ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch
• 00857167005290: ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box
• 00857167005283: ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch
• 00857167005009: ePlex System Base