Plasma Control 0250-XT2

GUDID 04250317555120

MassCheck® Antiepileptic Drugs XT2 Plasma Control Level I

Chromsystems Instruments + Chemicals GmbH

Multiple anticonvulsant therapeutic drug monitoring IVD, control

• Primary Device ID: 04250317555120
• NIH Device Record Key: 96672aa3-b654-4736-8cb5-223f0a440c57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasma Control
• Version Model Number: 0250-XT2
• Catalog Number: 0250-XT2
• Company DUNS: 328712260
• Company Name: Chromsystems Instruments + Chemicals GmbH
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com
• Phone: +498918930100
• Email: mailbox@chromsystems.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250317555120 [Package]; Contains: 04250317555137; Package: [5 Units]; In Commercial Distribution
GS1	04250317555137 [Primary]

FDA Product Code

• LAS: Drug Specific Control Materials

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: 2025-08-08
• Device Publish Date: 2025-07-31

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