FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Plasma Calibrator Set
DI: 04250317532565
·
Model: 92026/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
- 04250317532565
- Version / Model
- 92026/XT
- Catalog Number
- 92026/XT
- 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
- 2019-07-26
- Public Version
- 2
- Public Version Date
- 2022-01-25
- Public Version Status
- Update
- Public Device Record Key
- 88344f0a-224e-4a05-8e6e-2fbd13e3ac7b
- Distribution End Date
- 2022-01-24
Device Description
3PLUS1® Multilevel Plasma Calibrator Set MassTox® Neuroleptics 2/ 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 |
|---|---|---|---|---|
| 64333 | Multiple antipsychotic 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 antipsychotic drugs, also known as neuroleptic drugs which may include amisulpride, chlorprothixene, melperone and ziprazidone, 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 | 04250317532565 | 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