FDA.reportPublic FDA data

Atellica DT 250 Analyzer

Primary DI
15999883586744
Brand
Atellica DT 250 Analyzer
Company
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Model
Atellica DT 250
Catalog number
11310504
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.
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15999883586744PackageGS11In Commercial Distribution
05999883586747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1599988358674415999883586744
05999883586747059998835867475999883586747

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratoryAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth700Millimeter
Height660Millimeter
Width880Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity40 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8772293711contact@siemens-healthineers.com

Regulatory Flags#

DUNS number
427395277
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05999860094180Pictus 700 clinilcal chemistry analyzerPictus 700 clinilcal chemistry analyzer with ISEP700-32018-06-26
05999883586884Pictus 700 clinilcal chemistry analyzer Pictus 700 clinilcal chemistry analyzer W/out ISE P700-12018-06-26
05999883586891Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer W/out ISE P400-12018-06-26
25999860094153Trigger Solutions Pack226491-TRP2026-01-05
159998600941705x TBS Wash BufferTWB562025-12-11
059998600941735x TBS Wash BufferTWB562025-12-11
05999860094227Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with barcodP400-32018-06-26
05999860094234Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with ISE anP400-42018-06-26
05999883586686NA ELECTRODE, ISE MODULENA+ Electrode52012016-10-06
05999883586709CL ELECTRODE, ISE MODULECl- Electrode52032016-10-06
05999883586693K ELECTRODE, ISE MODULEK+ Electrode52022016-10-06
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleP780 Clinical Chemistry Analyzer with ISE moduleP780-12025-07-10
05999883586426P780 Clinical Chemistry AnalyzerP780 Clinical Chemistry AnalyzerP780-22025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Atellica DT Cuvettes (280pcs)113105122025-06-13
15999883586751Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586867Atellica DT Solution 4 (S4)Atellica DT Solution 4 (S4)113105102025-04-30
45999883586752Atellica DT Solution 2 (S2)Atellica DT Solution 2 (S2)113105082025-04-30
05999883586747Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
25999883586758Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586850Atellica DT Solution 3 (S3)Atellica DT Solution 3 (S3)113105052025-04-30

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