FDA UDI
In Commercial Distribution
🇺🇸 United States
DImension Vista® C1 Inhibitor Control
DI: 00842768006418
·
Model: 10445927
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- DImension Vista® C1 Inhibitor Control
- Primary DI
- 00842768006418
- Version / Model
- 10445927
- Catalog Number
- KC745
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 2
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 5f12084e-d7e6-4390-a0fc-4b418b155da6
Device Description
C1IN CON is an assayed, mid level, intralaboratory quality control for the assessment of precision and analytical bias in the determination of the C1IN method on the Dimension Vista® System
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
- No
- 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 |
|---|---|---|---|---|
| JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30506 | Plasma protein IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768006418 | GS1 | ||||
| Unit of Use | 00842768019340 | GS1 |
Customer Contacts
- Phone
- +1(800)441-9250
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072965 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius