Data / Medical devices / Detergent
Detergent (JCB): 35 FDA-registered makers in 12 countries
35 establishments in 12 countries are registered with the FDA to make Detergent (product code JCB, Class 1, 21 CFR 864.4010). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (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
- JCB
- Device class
- 1
- Regulation
- 864.4010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 16 |
| China | 6 |
| Italy | 3 |
| Germany | 2 |
| Poland | 1 |
| Sweden | 1 |
| Spain | 1 |
| Hungary | 1 |
| Canada | 1 |
| Turkey | 1 |
| Austria | 1 |
| Finland | 1 |
Makers of Detergent
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 | |
| B&e Bio-Technology Co., Ltd. | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Hialeah, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boule Medical AB | Spanga Stockholm, Sweden | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter GmbH | Krefeld North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Hebron, KY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Diagnostic Solutions, Inc. | Plantation, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Italia | BRESCIA Lombardy, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carolina Liquid Chemistries | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan WASP | Brescia Lombardy, Italy | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Grifols, S.A. | PARETS DEL VALLES Barcelona, Spain | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatron MI Plc | Budapest, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germiphene Corp. | BRANTFORD Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JAS Diagnostics/Drew Scientific | Plantation, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroCare Medical | Commerce City, CO, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Phoenix Diagnostics, Inc. | Natick, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Predo Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi | SEHITKAMIL Gaziantep, Turkey | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technoclone | Vienna Wien, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technogenetics SPA | Lodi, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermo Fisher Scientific OY | VANTAA Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| URIT Medical Electronic Co., Ltd. | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wavesense, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weiman Products, LLC | Gurnee, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.