Urine Control 0368

GUDID 04250317535788

MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level II

Chromsystems Instruments + Chemicals GmbH

Ethyl glucuronide (EtG) IVD, control

• Primary Device ID: 04250317535788
• NIH Device Record Key: 0a7eb827-52cb-4ecf-b1b8-bba6e87e8704
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Control
• Version Model Number: 0368
• Catalog Number: 0368
• 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: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de

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	04250317535788 [Package]; Contains: 04250317546067; Package: [5 Units]; In Commercial Distribution
GS1	04250317546067 [Primary]

FDA Product Code

• DKC: Alcohol 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: 2020-08-14
• Device Publish Date: 2020-08-06

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• 04250317501257: Urine Control Level II, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine
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• 04250317535795: MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level III
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• 04250317551184: MassCheck® Amino Acids Analysis, Plasma Control Level III
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