Urine Calibrator Set 80839

GUDID 04250317537706

6PLUS1® Multilevel Urine Calibrator Set MassChrom® VMA, HVA, 5-HIAA

Chromsystems Instruments + Chemicals GmbH

HVA/VMA/5HIAA IVD, calibrator HVA/VMA/5HIAA IVD, calibrator

• Primary Device ID: 04250317537706
• NIH Device Record Key: 63ad2db1-5a87-47f4-9778-937b4d1eed77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Calibrator Set
• Version Model Number: 80839
• Catalog Number: 80839
• 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

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250317537706 [Primary]

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

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: 2019-04-01
• Device Publish Date: 2019-03-22

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• 04250317537799: 6PLUS1® Multilevel Urine Calibrator Set MassChrom® Catecholamines, free Metanephrines, Seroton
• 04250317542342: 6PLUS1® Multilevel Urine Calibrator Set MassTox® Drugs of Abuse Testing in urine
• 04250317551115: 3PLUS1® Multilevel Urine Calibrator Set MassChrom® Amino Acid Analysis in urine