FDA UDI
In Commercial Distribution
🇺🇸 United States
LATEX CALIBRATORS
DI: 08056040141236
·
Model: LATEX CALIBRATORS
·
ALIFAX SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LATEX CALIBRATORS
- Primary DI
- 08056040141236
- Version / Model
- LATEX CALIBRATORS
- Catalog Number
- SI 305.400-A
- Company Name
- ALIFAX SRL
- Labeler DUNS
- 435930630
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-06
- Public Version
- 1
- Public Version Date
- 2022-10-14
- Public Version Status
- New
- Public Device Record Key
- 5f475f09-22ec-4c99-926a-ec52b23dba34
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
- 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 |
|---|---|---|---|---|
| GKB | Device, Automated Sedimentation Rate | Hematology | 864.5800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55971 | Erythrocyte sedimentation rate (ESR) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056040141236 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius