Clinitek Novus® Rinse Additive
Rinse additive for CLINITEK Novus® automated urine chemistry system.
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Jilin (1), Guangxi (1). 3 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 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JIL |
| Device type | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1340 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140717 |
| Record published | 2016-09-24 |
| Record revised | 2023-06-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10697754 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Teco Diagnostics | Teco Diagnostics | 19 |
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 11 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Henry Schein | Henry Schein, Inc. | 5 |
| Keto-Diastix® | Ascensia Diabetes Care US Inc. | 2 |
| Chemstrip 9 Urine Test Strips | Roche Diagnostics Gmbh | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Aution MAX™ AX-4060 Analyzer | Arkray USA, Inc. | 2 |
| Diastix® | Ascensia Diabetes Care US Inc. | 2 |
| Aimstrip US-3 | Germaine Laboratories, Inc. | 1 |
| Urine Strips | Urit Medical Electronic Co., Ltd. | 1 |
| Chemstrip 10 MD Test Strips | Roche Diagnostics Gmbh | 1 |
Showing 12 of 34. All products under Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091216 | 2009-10-09 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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.