DIALISA 2MP

Basic Information

• Brand Name: DIALISA 2MP
• Primary DI: 05060456180348
• Version / Model: 62003
• Catalog Number: 62003
• Company Name: DYNEX TECHNOLOGIES, INC.
• Labeler DUNS: 170119536
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-07
• Public Version: 3
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 3d604ef7-9895-435f-b23b-8c624ffdb449

Device Description

DIALISA 2MP, DS2 Automated ELISA Processing System

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	862.2300	1
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	862.2750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060456180345	GS1	Carton	1	In Commercial Distribution
Primary	05060456180348	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 70 Degrees Celsius