NeuMoDxTM 96 Molecular System 500200

GUDID 00814278020000

NeuMoDx 96 Molecular System

Neumodx Molecular, Inc.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 00814278020000
• NIH Device Record Key: 151b6f05-67e0-4b81-9875-f6bfc45c8d2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuMoDxTM 96 Molecular System
• Version Model Number: 500200
• Catalog Number: 500200
• Company DUNS: 078667309
• Company Name: Neumodx Molecular, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com
• Phone: +1(734)372-2617
• Email: ewinnega@neumodx.com

Device Dimensions

• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter
• Width: 137.2 Centimeter
• Height: 109.2 Centimeter
• Depth: 109.2 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814278020000 [Direct Marking]
GS1	10814278020007 [Primary]
GS1	10814278020724 [Primary]

FDA Product Code

• OOI: real time Nucleic acid amplification system

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: 2019-04-08
• Device Publish Date: 2019-03-29

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