OpsisDx ENT001

GUDID B550ENT0010

Four NuTec slides used to create bio-molecular profiles of samples

ENTOPSIS, LLC

Multiple-type clinical chemistry analyte profile IVD, reagent

• Primary Device ID: B550ENT0010
• NIH Device Record Key: 1edfd58f-d410-4348-be04-225ed78c0d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OpsisDx
• Version Model Number: NuTec Chamber
• Catalog Number: ENT001
• Company DUNS: 078294784
• Company Name: ENTOPSIS, LLC
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
HIBCC	B550ENT0010 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2021-09-03
• Device Publish Date: 2021-08-26

On-Brand Devices [OpsisDx]

• B550ENT0100: Metal tray used for quality control of OpsisDx heater
• B550ENT0070: Metal tray used to heat OpsisDx NuTec Slides
• B550ENT0040: Media used for quality control of the OpsisDx platform
• B550ENT0020: Additive used in preparing OpsisDx urine fixative and OpsisDx standard media
• B550ENT0010: Four NuTec slides used to create bio-molecular profiles of samples