FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasma Control
DI: 04250317543172
·
Model: 0231/XT
·
Chromsystems Instruments + Chemicals GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Plasma Control
- Primary DI
- 04250317543172
- Version / Model
- 0231/XT
- Catalog Number
- 0231/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
- 2020-07-30
- Public Version
- 1
- Public Version Date
- 2020-08-07
- Public Version Status
- New
- Public Device Record Key
- d7514124-f54e-4239-98bb-4614f72ce4c1
Device Description
MassCheck® Antidepressants 2 /Psychostimulants /EXTENDED Plasma Control Level I
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 |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62933 | Multiple antidepressant therapeutic drug monitoring IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of antidepressant drugs from multiple classes [e.g., tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), tetracyclic antidepressants (TeCAs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04250317542090 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04250317543172 | 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