FDA UDI
In Commercial Distribution
🇺🇸 United States
Immuno Control Set
DI: 08058056680204
·
Model: 11211A
·
SENTINEL CH. SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Immuno Control Set
- Primary DI
- 08058056680204
- Version / Model
- 11211A
- Catalog Number
- 11211A
- Company Name
- SENTINEL CH. SPA
- Labeler DUNS
- 429572365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-15
- Public Version
- 2
- Public Version Date
- 2020-02-25
- Public Version Status
- Update
- Public Device Record Key
- e84862e8-f8d8-4165-898c-d0af2cb448b7
Device Description
Immuno Control Set is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For professional use only. For In Vitro diagnostic use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 08058056680204 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store between 2 and 8 degrees Celsius