FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasma Calibrator Set
DI: 04250317548573
·
Model: 92051/XT
·
Chromsystems Instruments + Chemicals GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Plasma Calibrator Set
- Primary DI
- 04250317548573
- Version / Model
- 92051/XT
- Catalog Number
- 92051/XT
- Company Name
- Chromsystems Instruments + Chemicals GmbH
- Labeler DUNS
- 328712260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-17
- Public Version
- 1
- Public Version Date
- 2020-01-27
- Public Version Status
- New
- Public Device Record Key
- 5b79f64a-9986-4cee-8d96-38b7f2cb7e12
Device Description
3PLUS1® Multilevel Plasma Calibrator Set MassTox® Antimycotic Drugs/EXTENDED
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 |
|---|---|---|---|---|
| 64329 | Multiple antifungal therapeutic drug monitoring IVD, kit, liquid chromatography/mass spectrometry (LC/MS) | A collection of reagents and other associated materials 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, using a liquid chromatography/mass spectrometry (LC/MS) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250317548573 | GS1 |
Customer Contacts
- Phone
- +4989189300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Milliliter | |
| Device Size Text, specify | 4 vials |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -18 Degrees Celsius