xMAP® Sheath Fluid

GUDID 00840487100097

Sheath fluid is the delivery medium of the sample to the optics component.

LUMINEX CORPORATION

Multiplex analyser IVD, laboratory, semi-automated

• Primary Device ID: 00840487100097
• NIH Device Record Key: b5b1bd84-e847-41a3-b9f0-bc4640a745b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: xMAP® Sheath Fluid
• Version Model Number: 40-50000
• 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487100097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073506

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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