25OH Vitamin D Total Elisa
The 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in…
The 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient.
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 | American Laboratory Products Company, United States |
|---|---|
| FDA product code | MRG |
| Device type | System, Test, Vitamin D |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1825 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K123364 |
| Record published | 2017-01-18 |
| Record revised | 2018-07-06 (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 | Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 38-25DHU-E01 | 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 |
| IDS-iSYS 25 VitDS | Immunodiagnostic Systems Ltd. | 2 |
| Elecsys Vitamin D total III | Roche Diagnostics Gmbh | 2 |
Showing 12 of 50. All products under System, Test, Vitamin D
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| R & D Systems, Inc. | 510(k) number | 2018-09-11 | Class III | Unknown/Undetermined by firm | The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL. | 8 kits | 2020-09-01 |
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.