UA-Cellular for IQ
Urinalysis control designed specifically for the Iris Diagnostics iQ® automated urine analyzers. Contains 1 vial each of Level 1 & 2.
3manufacturers in China registered for this device type
1catalogue number
12510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Streck LLC, United States |
|---|---|
| FDA product code | JPK |
| Device type | Mixture, Hematology Quality Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K090201 |
| Record published | 2016-09-19 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 10 °C |
| Sizes | Total volume 120 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 213396 | Total Volume 120 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 140 |
| Liquichek | Bio-Rad Laboratories Inc. | 34 |
| Para 4 | Streck LLC | 17 |
| Drew Scientific | Drew Scientific, Ltd. | 15 |
| CVA | Streck LLC | 9 |
| Stat Profile | Nova Biomedical Corporation | 8 |
| Coulter 5C | Beckman Coulter, Inc. | 8 |
| Retic-Chex II | Streck LLC | 7 |
| BD Multi-Check | Becton, Dickinson AND Company | 6 |
| Cell-Chex Auto | Streck LLC | 6 |
| Coulter 4C-ES | Beckman Coulter, Inc. | 5 |
| Trinity Biotech | Primus Corp. | 4 |
Showing 12 of 97. All products under Mixture, Hematology Quality Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160588 | 2016-12-22 |
| K160590 | 2016-12-22 |
| K160586 | 2016-12-22 |
| K141964 | 2014-12-05 |
| K141957 | 2014-12-05 |
| K120742 | 2012-10-19 |
| K120744 | 2012-10-19 |
| K090201 | 2009-03-27 |
| K070199 | 2007-02-23 |
| K063218 | 2006-12-14 |
| K053362 | 2006-01-13 |
| K051706 | 2005-08-17 |
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.