MAGPIX® Calibration Kit

GUDID 00840487100271

The Luminex MAGPIX Calibration Kit is intended to calibrate the optics of the MAGPIX instrument. During calibration, the system adjusts LED current and calibration factors for CL1, CL2, and RP1 until those values match the imported target values, thus calibrating the classification map.

LUMINEX CORPORATION

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• Primary Device ID: 00840487100271
• NIH Device Record Key: 812a91d2-993b-4d07-9a13-b476e5b0c7cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGPIX® Calibration Kit
• Version Model Number: MPXIVD-CAL-K25
• Company DUNS: 965476641
• Company Name: LUMINEX CORPORATION
• 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: 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

Customer Support Contacts

• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487100271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121894

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

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