FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica DT Solution 4 (S4)
DI: 15999883586867
·
Model: Atellica DT Solution 4 (S4)
·
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Atellica DT Solution 4 (S4)
- Primary DI
- 15999883586867
- Version / Model
- Atellica DT Solution 4 (S4)
- Catalog Number
- 11310510
- 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
- a4d909bd-e8a2-403d-a375-a719aaf37ccd
Device Description
Atellica DT Solution 4 (S4) is used for the automatic decontamination and cleaning of cuvettes after each use and for the removal of any reagent, blood component, urine or CSF and lipoprotein deposits.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JCB | Detergent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25999883586864 | GS1 | Cardboard box | 6 | In Commercial Distribution | |
| Primary | 15999883586867 | GS1 |
Customer Contacts
- Phone
- +872293711
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 32 Degrees Celsius