Nova
Nova MAX DME Glucose Test Strips
20manufacturers in China registered for this device type
6catalogue numbers in this listing
6510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone | Jiangsu | Contract manufacturer | 2 |
| Dongguan Kaifa Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter
Record
| Listed by | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-16 |
| Record revised | 2019-08-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 15 to 30 °C; Storage environment temperature 15 to 30 °C; Special storage condition: Do not freeze |
| Packaging | Carton of 250, carton of 20, box |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MAX | 10 | In distribution | |
| SUREFLEX | In distribution | ||
| SUREFLEX | In distribution | ||
| SUREFLEX | 30 | In distribution | |
| MAX | 50 | In distribution | |
| SUREFLEX | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 40 |
| Fora | Fora Care Inc. | 31 |
| True Metrix AIR | Trividia Health, Inc. | 21 |
| GE | Bionime Corporation | 21 |
| TRUEtrack | Trividia Health, Inc. | 17 |
| Medline | Medline Industries, Inc. | 15 |
| AgaMatrix | Agamatrix | 15 |
| Tenovi | Tenovi Co | 13 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 11 |
| Accu-Chek Guide | Roche Diagnostics Operations | 10 |
| Curaplex | Bound Tree Medical, LLC | 10 |
| OneTouch Verio | Lifescan Europe Gmbh | 10 |
Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170464 | 2017-11-07 |
| K160156 | 2016-06-23 |
| K131013 | 2013-10-17 |
| K112638 | 2012-03-09 |
| K091547 | 2010-01-15 |
| K070255 | 2007-06-13 |
Recalls
10 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 32,452,700 test strips | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 9,200 | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 366,140 test strips | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | *Kitted into System Kits 43435 and 45507 | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 22,395,802 test strips | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 1,316,420 kits | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 28,240 kits | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 721,810 test strips | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 1,564,500 test strips | 2017-08-01 |
| 2013-07-15 | Class I | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips | 13,600 kits | 2017-08-01 |
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.