Reagent Kit

Basic Information

• Brand Name: Reagent Kit
• Primary DI: 04250317513229
• Version / Model: 6000/A5
• Catalog Number: 6000/A5
• 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: e2a2ca81-9bd5-4625-a6e9-8e0ed7fab61b

Device Description

HPLC Reagent Kit, Preparation with Gilson® Aspec, Catecholamines 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
CHQ	Chromatographic/Fluorometric Method, Catecholamines	Clinical Chemistry	862.1165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63823	Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple biogenic amine neurotransmitters [e.g., catecholamines (dopamine, norepinephrine, epinephrine), histamine, serotonin] and/or multiple biogenic amine neurotransmitter intermediate metabolites (e.g., metanephrine, normetanephrine, 3-methoxytyramine) in a clinical specimen, using a liquid chromatography method. It is typically used as an aid in the diagnosis of catecholamine-secreting tumours (e.g., pheochromocytoma).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250317513229	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			500 analyses