Data / Medical devices / Stain, Reticulocyte
Stain, Reticulocyte (GJH): 17 FDA-registered makers in 5 countries
17 establishments in 5 countries are registered with the FDA to make Stain, Reticulocyte (product code GJH, Class 1, 21 CFR 864.1850). 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 February 15, 1979, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- GJH
- Device class
- 1
- Regulation
- 864.1850
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Japan | 2 |
| Ireland | 1 |
| China | 1 |
| Germany | 1 |
Makers of Stain, Reticulocyte
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Ireland | Sligo, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ENG Scientific LLC | New Brunswick, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinan Babio Biotechnology Co.,ltd. | Jinan City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Pocomoke City, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Arlington, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Batesville, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard-Allan Scientific LLC | Kalamazoo, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rocky Mountain Reagents, Inc. | Golden, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sigma-Aldrich Manufacturing, LLC-H&H | Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Ono Factory | Ono Hyogo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Europe SE | Neumunster Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volusol | Tooele, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 15, 1979. 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.