FDA UDI
In Commercial Distribution
🇺🇸 United States
IDS-iSYS 25 VitDS Calibration Verifiers
DI: 05060169690929
·
Model: IS-2535
·
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- IDS-iSYS 25 VitDS Calibration Verifiers
- Primary DI
- 05060169690929
- Version / Model
- IS-2535
- Company Name
- IMMUNODIAGNOSTIC SYSTEMS LIMITED
- Labeler DUNS
- 494268600
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-22
- Public Version
- 3
- Public Version Date
- 2022-12-19
- Public Version Status
- Update
- Public Device Record Key
- 0cdd4d14-6344-4244-b1b3-2a7a769a79e7
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
- 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 |
|---|---|---|---|---|
| 54474 | Multiple form 25-hydroxy Vitamin D IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060169690929 | GS1 |
Customer Contacts
- Phone
- +4401915190660
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111650 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the calibration verifiers in an upright position.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius