Iq®200
iQ® Control/Focus Set (NA/INTL)
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (1), Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
Record
| Listed by | Beckman Coulter Ireland Inc, Ireland |
|---|---|
| FDA product code | JJW |
| Device type | Urinalysis Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-07 |
| Record revised | 2023-10-13 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| iQ® Control/Focus Set (NA/INTL) | In distribution | |
| iQ® Calibrator | In distribution | |
| iQ Precision Kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kova | Kova International Inc | 52 |
| Urine Control | Chromsystems Instruments & Chemicals Gmbh | 16 |
| Urinalysis Controls (Assayed And Unassayed) | Alta Diagnostics, Inc. | 14 |
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| qUAntify | Bio-Rad Laboratories Inc. | 10 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| DxU | Beckman Coulter, Inc. | 6 |
| Cardinal Health | Kova International Inc | 6 |
| MAS UA Control Liquid Assayed Urinalysis Control | Microgenics Corporation | 5 |
| Quality Control Solution For Urine Analyzer | Urit Medical Electronic Co., Ltd. | 4 |
| Urine Control Bi-Level | Chromsystems Instruments & Chemicals Gmbh | 4 |
| Mission Liquid Urine Controls | Acon Laboratories, Inc. | 4 |
Showing 12 of 77. All products under Urinalysis Controls (Assayed And Unassayed)
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.