Urinalysis Controls (Assayed and Unassayed)
Liquid Urine Control Dipstick - Negative/Positive, 20 ml. Contains 3 vials Negative and 3 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when…
Liquid Urine Control Dipstick – Negative/Positive, 20 ml. Contains 3 vials Negative and 3 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
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 | Alta Diagnostics, Inc., United States |
|---|---|
| FDA product code | JJW |
| Device type | Urinalysis Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Repacker / relabeller |
| 510(k) | K890577 |
| Record published | 2019-03-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C |
| Packaging | Box of 6, box of 4 |
| Sizes | Total volume 10 to 250 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 323-16-1 | Total Volume 10 ml | In distribution |
| 303-1 | Total Volume 30 ml | In distribution |
| 323-16-2 | Total Volume 10 ml | In distribution |
| 301-1 | Total Volume 20 ml | In distribution |
| 323-17-1 | Total Volume 25 ml | In distribution |
| 301-2 | Total Volume 20 ml | In distribution |
| 301-3 | Total Volume 250 ml | In distribution |
| 303-2 | Total Volume 30 ml | In distribution |
| 323-17-2 | Total Volume 25 ml | In distribution |
| 303-12 | Total Volume 30 ml | In distribution |
| 301-12 | Total Volume 20 ml | In distribution |
| 323-17-12 | Total Volume 25 ml | In distribution |
| 301-4 | Total Volume 250 ml | In distribution |
| 323-16-12 | Total Volume 10 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kova | Kova International Inc | 52 |
| Urine Control | Chromsystems Instruments & Chemicals Gmbh | 16 |
| 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 |
| Liquichek | Bio-Rad 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.