Data / Medical devices / Tube, Sedimentation Rate
Tube, Sedimentation Rate (GHC): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Tube, Sedimentation Rate (product code GHC, Class 1, 21 CFR 864.6700). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 15, 1989, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GHC
- Device class
- 1
- Regulation
- 864.6700
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| United States | 3 |
| Spain | 1 |
| Italy | 1 |
| Germany | 1 |
Makers of Tube, Sedimentation Rate
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 |
|---|---|---|---|---|---|---|---|---|
| Aquisel S.L. | Abrera Barcelona, Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cor Health, Inc | Laramie, WY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diesse Diagnostica Senese S.P.A | MONTERIGGIONI Siena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GUILIN YIKESHI Medical Device CO LTD | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | JIANGYAN Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rongye Technology Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivosens Inc | San Francisco, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 15, 1989. 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.