Clinitek Status® Connector
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care…
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzers. The connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Who Else Makes It
Concentrated in Zhejiang (5), Jilin (5), Jiangsu (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Guangdong Kawada Sanitary Products Co., Ltd. Southern District Branch Company. | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
Showing 12 of 16. All 16 manufacturers in China registered for Dye-Indicator, Ph (Urinary, Non-Quantitative)
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | CEN |
| Device type | Dye-Indicator, Ph (Urinary, Non-Quantitative) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1550 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K091216 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Special storage condition: Max 95% RH at 45’c; Storage environment temperature 5 to 40 °C; Handling environment temperature -20 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10376323 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 7 |
| Teco Diagnostics | Teco Diagnostics | 7 |
| Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | 2 |
| Ezy Dose | Apothecary Products, LLC. | 2 |
| GoldN Easy to Use Vaginal pH Test | Novodx Corporation | 1 |
| Just Fitter pH Test Strips | DFI Co., Ltd. | 1 |
| Feminine Screening Kit | Peptonic Medical Israel Ltd | 1 |
| Feminine Screening Kit | Savyon Diagnostics Ltd. | 1 |
| One+Step pH | DFI Co., Ltd. | 1 |
| Vagi-Screen Vaginal Health Test | Peptonic Medical Israel Ltd | 1 |
| VagiVital VS | Peptonic Medical Israel Ltd | 1 |
| Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 29. All products under Dye-Indicator, Ph (Urinary, Non-Quantitative)
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-09-19 | Class II | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. | approx. 4200 | 2015-07-20 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-09-19 | Class II | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. | approx. 4200 | 2015-07-20 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-09-19 | Class II | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. | approx. 4200 | 2015-07-20 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2013-02-26 | Class III | Reprocessing Controls | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | 1 unit | 2014-05-06 |
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.