Clinitek Novus® Automated Urine Chemistry Analyzer
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens…
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Who Else Makes It
Concentrated in Jilin (6), Zhejiang (2), Guangxi (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 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
Showing 12 of 14. All 14 manufacturers in China registered for Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JIR |
| Device type | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1645 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140717 |
| Record published | 2016-09-24 |
| Record revised | 2022-09-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 65 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10697937 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 12 |
| Teco Diagnostics | Teco Diagnostics | 5 |
| Rapid Response | Btnx Inc. | 3 |
| Cybow P | DFI Co., Ltd. | 2 |
| Total Protein (UP) | Randox Laboratories Limited | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Tinaquant Albumin | Roche Diagnostics Gmbh | 2 |
| Micro-albumin Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Multistix® 9 SG Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Chemstrip Micral Urine Test Strips | Roche Diagnostics Gmbh | 1 |
| Micro Protein (CSF/Urine) LiquiColor® | Stanbio Laboratory, L.P. | 1 |
| Uri-Trak 120 M Urine Analyzer | Stanbio Laboratory, L.P. | 1 |
Showing 12 of 36. All products under Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Recalls
4 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 |
|---|---|---|---|---|
| 2026-07-06 | Class II | Under Investigation by firm | processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c | 7018 units |
| 2026-01-20 | Class II | Under Investigation by firm | Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL. | 4,885 units |
| 2024-08-15 | Class II | Nonconforming Material/Component | Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, AD | 18483 units |
| 2024-08-15 | Class II | Nonconforming Material/Component | Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, AD | 19645 units |
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.