JAS Diagnostics
GLUCOSE OXIDASE LIQUID REAGENT (1x 125mL) Unlabeled Vial
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (2), Jiangsu (1). 4 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 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | Drew Scientific, Ltd., United Kingdom |
|---|---|
| FDA product code | CGA |
| Device type | Glucose Oxidase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| 510(k) | K970781 |
| Record published | 2016-09-09 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DG-GLO2-125 | In distribution | |
| GLU2-125 | In distribution | |
| GLO2-125U | In distribution | |
| DG-GLO2-1L | In distribution | |
| GLO2-125 | In distribution | |
| GLO2-BUP | In distribution | |
| GLUS-3U | In distribution | |
| GLU2-1L | In distribution | |
| GLO2-1LU | In distribution | |
| GLO2-1L | In distribution | |
| XL-GLU2-40 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| i-STAT | Abbott Point OF Care Inc. | 48 |
| YSI Incorporated | YSI Incorporated | 34 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 28 |
| Stat Profile | Nova Biomedical Corporation | 17 |
| Fora | Fora Care Inc. | 13 |
| TRUEtrack | Trividia Health, Inc. | 12 |
| StatStrip | Nova Biomedical Corporation | 9 |
| Gluc-PAP | Randox Laboratories Limited | 8 |
| Nova Primary | Nova Biomedical Corporation | 8 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Prodigy No Coding Blood Glucose Test Strips | Prodigy Diabetes Care, LLC | 7 |
| StatSensor/StatStrip | Nova Biomedical Corporation | 6 |
Showing 12 of 215. All products under Glucose Oxidase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070704 | 2007-07-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| JAS Diagnostics/Drew Scientific | 510(k) number | 2014-04-07 | Class II | Mixed-up of materials/components | JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications. | 407 | 2014-08-21 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990026 | 2002-02-04 | CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. |
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.