Reagent

Basic Information

• Brand Name: Reagent
• Primary DI: 04250317537812
• Version / Model: 80815
• Catalog Number: 80815
• Company Name: Chromsystems Instruments + Chemicals GmbH
• Labeler DUNS: 328712260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-27
• Public Version: 1
• Public Version Date: 2020-09-04
• Public Version Status: New
• Public Device Record Key: e394ffd7-0a7b-4b43-af10-b1a758259fa9

Device Description

Tuning Mix, MassChrom® VMA, HVA, 5-HIAA in urine

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CDF	Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin	Clinical Chemistry	862.1795	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60612	HVA/VMA/5HIAA IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qquantitative measurement of homovanillic acid (HVA), vanillylmandelic acid (VMA) and 5-hydroxyindoleacetic acid (5HIAA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250317537812	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 ml

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -18 Degrees Celsius