FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasma Calibration Standard
DI: 04250317544858
·
Model: 27034
·
Chromsystems Instruments + Chemicals GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Plasma Calibration Standard
- Primary DI
- 04250317544858
- Version / Model
- 27034
- Catalog Number
- 27034
- Company Name
- Chromsystems Instruments + Chemicals GmbH
- Labeler DUNS
- 328712260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-26
- Public Version
- 1
- Public Version Date
- 2019-08-05
- Public Version Status
- New
- Public Device Record Key
- 2de3cf66-460f-49fe-9e90-e98f6ff94951
Device Description
Plasma Calibration Standard Itraconazole, Posaconazole, Voriconazole
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 |
|---|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64332 | Multiple antifungal therapeutic drug monitoring IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple antifungal/antimycotic drugs (e.g., fluconazole, 5-flucytosine, itraconazole, voriconazole and ketoconazole) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04250317522375 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04250317544858 | GS1 |
Customer Contacts
- Phone
- +4989189300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5 x 1ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -18 Degrees Celsius