FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Plasma Calibration Standard
DI: 04250317543752
·
Model: 49003
·
Chromsystems Instruments + Chemicals GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
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
- Plasma Calibration Standard
- Primary DI
- 04250317543752
- Version / Model
- 49003
- Catalog Number
- 49003
- Company Name
- Chromsystems Instruments + Chemicals GmbH
- Labeler DUNS
- 328712260
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-22
- Public Version
- 2
- Public Version Date
- 2024-12-18
- Public Version Status
- Update
- Public Device Record Key
- 357d5bfb-78a2-4eca-bf09-fa6b20354a01
- Distribution End Date
- 2024-12-17
Device Description
Plasma Calibration Standard Benzodiazepines, Tricyclic Antidepressants
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 |
|---|---|---|---|---|
| 55234 | Multiple-therapy 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 drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04250317510433 | GS1 | 5 | Not in Commercial Distribution | 2024-12-17 | |
| Primary | 04250317543752 | GS1 |
Customer Contacts
- Phone
- +4989189300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5 x 2.5ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius