1,25 Dihydroxy Vitamin D RIA
2 catalogue numbers from AA-54F1, listed by Immunodiagnostic Systems Ltd., United Kingdom, under System, Test, Vitamin D. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
9510(k) clearances naming this product code
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) | K042519 |
| Record published | 2016-04-01 |
| 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 | Special storage condition: Store radioactive materials in the original container in a specifically designated properly labelled area; Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AA-54F1 | In distribution | |
| AA-54F2 | 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 |
| 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 |
| 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.