Dipper Urinalysis Dipstick Control Level 2 Set 6x15ml
The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory…
The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.
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 | Quantimetrix Corp., United States |
|---|---|
| FDA product code | JJW |
| Device type | Urinalysis Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K874890 |
| Record published | 2018-09-26 |
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 8 °C; Handling environment temperature 18 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1442-61 | 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142262 | 2015-04-10 |
| K831526 | 1983-08-12 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2024-09-17 | Class II | Packaging process control | The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients’ results. | 1 BOX | |
| Quantimetrix Corp. | 510(k) number | 2017-12-21 | Class III | Mixed-up of materials/components | The kits contained an incorrect lot of Dropper Plus Level 1 vials | 20 kits | 2021-01-27 |
| Quantimetrix Corp. | 510(k) number | 2007-06-01 | Not classified | Employee error | This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group. | 24,937 sets for all products. | 2009-02-18 |
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.