The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use,…
The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use, requiring no reconstitution of dilution. The controls are formulated from a simulated urine matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated to target levels with compounds that produce the desired reaction when tested by methods indicated in the product insert.
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.
Record
Regulatory record for Dipper Poct Level 1&2 Set 62×1.5mL | 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 |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| 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 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
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.