FDA UDI
In Commercial Distribution
🇺🇸 United States
iSED Elite
DI: 00850028040041
·
Model: 112-00222
·
ALCOR SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iSED Elite
- Primary DI
- 00850028040041
- Version / Model
- 112-00222
- Catalog Number
- 112-00222
- Company Name
- ALCOR SCIENTIFIC INC.
- Labeler DUNS
- 884153748
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-03
- Public Version
- 1
- Public Version Date
- 2023-11-13
- Public Version Status
- New
- Public Device Record Key
- c6710d03-89fb-460d-a0c2-f5cbe52c4a2e
Device Description
Automated Erythrocyte Sedimentation Rate Analyzer
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
- Yes
- 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 |
|---|---|---|---|---|
| GKB | Device, Automated Sedimentation Rate | Hematology | 864.5800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56691 | Erthrocyte sedimentation rate (ESR) analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850028040041 | GS1 |