FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica DT Cuvettes (280pcs)
DI: 05999883586907
·
Model: Atellica DT Cuvettes (280pcs)
·
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Atellica DT Cuvettes (280pcs)
- Primary DI
- 05999883586907
- Version / Model
- Atellica DT Cuvettes (280pcs)
- Catalog Number
- 11310512
- 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
- 2025-06-13
- Public Version
- 1
- Public Version Date
- 2025-06-23
- Public Version Status
- New
- Public Device Record Key
- 82a97ee5-a321-4312-9399-60e182122d52
Device Description
The cuvette strips are manufactured especially for Atellica® DT 250 Analyzer and are intended to use for performing tests only on those instruments.
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
- 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 |
|---|---|---|---|---|
| 61033 | Laboratory analyser cuvette IVD, reusable | A small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through sample and is typically made of plastic, glass or quartz with a flat base and an open top. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05999883586907 | GS1 |
Customer Contacts
- Phone
- +872293711
- [email protected]