FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Selectra
DI: 03661540600401
·
Model: ProM
·
ELITechGroup B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Selectra
- Primary DI
- 03661540600401
- Version / Model
- ProM
- Catalog Number
- 6003-436
- Company Name
- ELITechGroup B.V.
- Labeler DUNS
- 415733737
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-18
- Public Version
- 5
- Public Version Date
- 2021-12-29
- Public Version Status
- Update
- Public Device Record Key
- 906b3853-65d5-4ead-9016-9267fde4c7cc
- Distribution End Date
- 2021-12-23
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | Clinical Chemistry | 862.1665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56679 | Multiple clinical chemistry analyser IVD, laboratory, semi-automated | An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540600401 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102647 | 000 |