Atellica DT 250 Analyzer

Basic Information

• Brand Name: Atellica DT 250 Analyzer
• Primary DI: 05999883586747
• Version / Model: Atellica DT 250
• Catalog Number: 11310504
• Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
• Labeler DUNS: 427395277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-30
• Public Version: 1
• Public Version Date: 2025-05-08
• Public Version Status: New
• Public Device Record Key: d658937a-1bf2-4711-9d4a-03028fac0896

Device Description

The Atellica® DT 250 analyzer is a fully automated wet-chemistry analyzer for in vitro diagnostic use. The analyzer is used to measure a variety of analytes by photometric principle in human samples, in a quantitative way, with reagents that may be adaptable. The Atellica® DT 250 Analyzer menu is focused on Drugs of Abuse Testing assays (DAT), Therapeutic Drug Monitoring (TDM) assays, and Immunosuppressant Drug (ISD) assays.

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
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	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	15999883586744	GS1	Wooden box	1	In Commercial Distribution
Primary	05999883586747	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	660	Millimeter
Depth	700	Millimeter
Width	880	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 40 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity