AccessGUDID - DEVICE: Atellica DT Solution 2 (S2) (45999883586752)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica DT Solution 2 (S2)
Version or Model: Atellica DT Solution 2 (S2)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11310508
Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Primary DI Number: 45999883586752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 427395277 *Terms of Use

Device Description: Atellica DT Solution 2 (S2) contains detergents, for regular cleaning and rinsing of Atellica DT 250 Analyzer’s probes, cuvettes, and tubings removing reagents, samples and protein deposits.

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):	Yes
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?
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCB	Detergent

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
Storage Environment Temperature: between 4 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 13f4a47d-e0b7-46a5-8c4c-3e49d2403268
Public Version Date: May 08, 2025
Public Version Number: 1
DI Record Publish Date: April 30, 2025