IDS-iSYS 25 VitDS
IDS-iSYS 25 VitDS is a laboratory assay for measuring total 25-hydroxyvitamin D in human serum or plasma. It runs on the IDS-iSYS Multi-Discipline Automated System, with results used…
IDS-iSYS 25 VitDS is a laboratory assay for measuring total 25-hydroxyvitamin D in human serum or plasma. It runs on the IDS-iSYS Multi-Discipline Automated System, with results used alongside other clinical and laboratory information to assess vitamin D sufficiency in adults.
The assay uses magnetic particles and an acridinium label to generate a chemiluminescent signal. Its reagent cartridge provides 100 tests and is supplied with two calibrator concentrations in a human serum buffer matrix.
Laboratory Handling
The kit is for prescription in vitro diagnostic use. Sample preparation occurs on the analyzer, using a 10 µL sample volume. Reagents are stored at 2 to 8°C, and calibration uses two points to adjust the batch master curve.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Immunodiagnostic Systems Ltd., United Kingdom |
|---|---|
| FDA product code | MRG |
| Device type | System, Test, Vitamin D |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1825 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K161831 |
| Record published | 2019-09-26 |
| Record revised | 2022-12-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Store the cartridge in an upright position in the dark at 2 – 8 °C. Do not freeze the cartridge |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IS-2500N | In distribution | |
| IS-2500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 6 |
| Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | 3 |
| Maglumi 25-OH Vitamin D | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 3 |
| Architect | Abbott Medical | 3 |
| Atellica™ IM VitD | Siemens Healthcare Diagnostics Inc | 2 |
| 1,25 Dihydroxy Vitamin D RIA | Immunodiagnostic Systems Ltd. | 2 |
| Maglumi 2000 25-OH Vitamin D | Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | 2 |
| Alinity | Abbott Ireland | 2 |
| Architect | Abbott Ireland | 2 |
| Elecsys Vitamin D total II | Roche Diagnostics Gmbh | 2 |
| Elecsys Vitamin D total III | Roche Diagnostics Gmbh | 2 |
| Advia Centaur® VitD | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 50. All products under System, Test, Vitamin D
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161831 | 2016-11-15 |
| K142351 | 2015-08-25 |
| K140554 | 2014-12-19 |
| K123253 | 2013-06-18 |
| K091849 | 2010-06-25 |
| K051110 | 2005-07-06 |
| K042519 | 2004-12-01 |
| K021163 | 2002-05-10 |
| K991998 | 1999-09-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.