Ketone Urine Controls
Ketone Urine Controls is an assayed urine control intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes:…
Ketone Urine Controls is an assayed urine control intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic Acid, Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specify Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and human Chorionic Gonadotropin.
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 | Stanbio Laboratory, L.P. |
|---|---|
| FDA product code | JJW |
| Device type | Urinalysis Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Premarket notification | Exempt |
| Record published | 2019-03-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4020-005 | 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.