FDA UDI
In Commercial Distribution
🇺🇸 United States
DImension Vista® Protein 1 Control M (medium)
DI: 00842768006340
·
Model: 10445920
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- DImension Vista® Protein 1 Control M (medium)
- Primary DI
- 00842768006340
- Version / Model
- 10445920
- Catalog Number
- KC716
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- 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
- a808a710-ad65-485e-8c9a-4af71a199036
Device Description
PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias 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 |
|---|---|---|---|---|
| JJY | Multi-analyte controls, all kinds (assayed) | 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 | 00842768006340 | GS1 | ||||
| Unit of Use | 00842768019425 | GS1 |
Customer Contacts
- Phone
- +1(800)441-9250
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083463 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius