Data / Medical devices / Colorimetric Method, Triglycerides
Colorimetric Method, Triglycerides (JGY): 26 FDA-registered makers in 7 countries
26 establishments in 7 countries are registered with the FDA to make Colorimetric Method, Triglycerides (product code JGY, Class 1, 21 CFR 862.1705). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on April 24, 2012, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JGY
- Device class
- 1
- Regulation
- 862.1705
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 14 |
| China | 5 |
| South Korea | 3 |
| Norway | 1 |
| Egypt | 1 |
| Taiwan | 1 |
| Argentina | 1 |
Makers of Colorimetric Method, Triglycerides
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Polymer Technology Systems | Whitestown, IN, United States | Complaint file establishment, Manufacturer | 2 | July 3, 2000 | 0 | 0 | 0 | api.fda.gov |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 1 | April 21, 1997 | 0 | 0 | 0 | api.fda.gov |
| Abaxis, Inc. | Union City, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acon Biotech (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acon Laboratories, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Diagnostics Technologies AS | Oslo, Norway | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Bao Kang Dian Zi Ke Ji Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elhoda Trade And Supplies | Badr industerial city Al Qahirah, Egypt | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| East West Wisconsin | Whitewater, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Home Access Health Corp. | Hoffman Est, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ixensor Co Ltd | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| OSANG Healthcare CO., LTD. | ANYANG Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osang LLC | S Pasadena, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SD Biosensor, Inc. | Suwon-si Gyeonggi, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SD Biosensor, Inc. | Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| URIT Medical Electronic Co., Ltd. | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 24, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.