Plamsa Control

Basic Information

• Brand Name: Plamsa Control
• Primary DI: 04250317545312
• Version / Model: 0245
• Catalog Number: 0245
• Company Name: Chromsystems Instruments + Chemicals GmbH
• Labeler DUNS: 328712260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-06
• Public Version: 1
• Public Version Date: 2020-08-14
• Public Version Status: New
• Public Device Record Key: fd93480a-c82e-4089-b4be-4d761c5138b0

Device Description

MassCheck® Tricylclic Antidepressants TCA 1, Plasma Control Level II

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
LAS	Drug Specific Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55817	Tricyclic antidepressant IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04250317524287	GS1		5	In Commercial Distribution
Primary	04250317545312	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5 x 1ml

Storage Conditions

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