Reagent Kit

Basic Information

• Brand Name: Reagent Kit
• Primary DI: 04250317537423
• Version / Model: 80800/96
• Catalog Number: 80800/96
• 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: 16009da0-2921-4052-b2f9-91a66c0049a8

Device Description

MassChrom® Biogenic Amines/Metabolites in urine, Sample Prep Set VMA, HVA, 5-HIAA including collection plates

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
63929	HVA/VMA/5HIAA IVD, kit, liquid chromatography/mass spectrometry (LC/MS)	A collection of reagents and other associated materials to be used for the quantitative measurement of homovanillic acid (HVA), vanillylmandelic acid (VMA), and 5-hydroxyindoleacetic acid (5HIAA) in a clinical specimen, using a liquid chromatography/mass spectrometry (LC/MS) method. It is typically used to aid in the diagnosis of neuroblastoma.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250317537423	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			96 analyses