Biobase
4 catalogue numbers from R1:20mL×1 R2:5mL×1, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Colorimetric Method, Triglycerides. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (1), Guangxi (1). 2 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 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
Record
| Listed by | Biobase Biodustry(Shandong)Co., Ltd., China |
|---|---|
| FDA product code | JGY |
| Device type | Colorimetric Method, Triglycerides |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1705 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R1:20mL×1 R2:5mL×1 | In distribution | |
| R1:20mL×4 R2:5mL×4 | In distribution | |
| R1:64mL×2 R2:16mL×2 | In distribution | |
| R1:60mL×5 R2:15mL×5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alere Cholestech LDX® | Alere San Diego, Inc. | 2 |
| Piccolo Lipid Panel Plus | Abaxis, Inc. | 1 |
| PTS Panels® Lipid Panel Test Strips | Polymer Technology Systems | 1 |
| AimStrip Tandem Total Triglycerides Test Strips | Germaine Laboratories, Inc. | 1 |
| PTS Panels® Lipid Panel Test Strips (10-ct) | Polymer Technology Systems | 1 |
| Cholestech LDX™ | Alere San Diego, Inc. | 1 |
| Piccolo Lipid Panel | Abaxis, Inc. | 1 |
| Lipid Panel, 15ct., CCPlus Home | Polymer Technology Systems | 1 |
| Mission Cholesterol Meter | Acon Laboratories, Inc. | 1 |
| PTS Panels® Triglycerides Test Strips | Polymer Technology Systems | 1 |
| CardioChek® PA Professional Analyzer, Refurbished | Polymer Technology Systems | 1 |
| Curo L5 TG test strip | Osang Healthcare Co., Ltd. | 1 |
Showing 12 of 13. All products under Colorimetric Method, Triglycerides
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.