Data / Medical devices / Romanowsky Stains
Romanowsky Stains (GJL): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make Romanowsky Stains (product code GJL, 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 April 1, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GJL
- Device class
- 1
- Regulation
- 864.1850
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Poland | 1 |
| Germany | 1 |
| Canada | 1 |
| South Korea | 1 |
| France | 1 |
Makers of Romanowsky Stains
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 Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avantor Performance Materials Poland S.A. | Gliwice Slaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Gram Diagnostics GMBH | Worms Rhineland-Palatinate, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chaptec America | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethos Biosciences, INC. | Logan Township, NJ, United States | Contract manufacturer, 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 | |
| Noul Co., Ltd. | Yongin Si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ral Diagnostics | Martillac Gironde, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volusol | Tooele, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 1, 1988. 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.