AccessGUDID - DEVICE: Atellica DT 250 Analyzer (05999883586747)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica DT 250 Analyzer
Version or Model: Atellica DT 250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11310504
Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Primary DI Number: 05999883586747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 427395277 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 18 and 30 Degrees Celsius
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Handling Environment Humidity: between 40 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Height: 660 Millimeter
Depth: 700 Millimeter
Width: 880 Millimeter

Device Record Status

Public Device Record Key: d658937a-1bf2-4711-9d4a-03028fac0896
Public Version Date: May 08, 2025
Public Version Number: 1
DI Record Publish Date: April 30, 2025