Data / Medical devices / Enzyme Immunoassay, Phencyclidine
Enzyme Immunoassay, Phencyclidine (LCM): 61 FDA-registered makers in 8 countries
61 establishments in 8 countries are registered with the FDA to make Enzyme Immunoassay, Phencyclidine (product code LCM, Class U). 21 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 88 510(k) clearances under this code, the latest on April 18, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LCM
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 35 |
| China | 18 |
| Germany | 2 |
| United Kingdom | 2 |
| Jordan | 1 |
| Australia | 1 |
| Indonesia | 1 |
| Switzerland | 1 |
Makers of Enzyme Immunoassay, Phencyclidine
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 |
|---|---|---|---|---|---|---|---|---|
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 3 | April 8, 2011 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 3 | May 15, 2001 | 0 | 0 | 0 | api.fda.gov |
| Alfa Scientific Designs, Inc. | Poway, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 2 | May 29, 2001 | 0 | 0 | 0 | api.fda.gov |
| Alere San Diego, Inc. | Pomona, CA, United States | Manufacturer, Manufacturer for export | 2 | April 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Omega Laboratories, Inc. | Mogadore, OH, United States | Manufacturer | 2 | June 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | January 27, 2000 | 0 | 0 | 0 | api.fda.gov |
| Alere San Diego, Inc. | San Diego, CA, United States | Specification developer | 1 | August 9, 2001 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | December 7, 1994 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Specification developer | 1 | August 9, 2001 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | May 29, 2001 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | August 9, 2001 | 0 | 0 | 0 | api.fda.gov |
| Lin-Zhi International, Inc. | Santa Clara, CA, United States | Manufacturer | 1 | May 10, 2002 | 0 | 0 | 0 | api.fda.gov |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 1 | September 28, 2000 | 0 | 0 | 0 | api.fda.gov |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 1 | September 28, 2000 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 1 | November 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | November 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Phamatech Inc. | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 1 | February 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 1 | May 31, 1996 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 1 | May 31, 1996 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 1 | May 31, 1996 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | January 10, 2005 | 0 | 0 | 0 | api.fda.gov |
| Abon Biopharm (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ABOUND Diagnostics, Inc | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advin Biotech, Inc. | San Diego, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ark Diagnostics Inc | Fremont, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atlas Medical | Amman Al 'Asimah, Jordan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Calbiotech, Inc. | El Cajon, CA, United States | Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Co-Innovation Biotech Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemtron Biotech, Inc. | San Diego, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Laihe Biotech Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hongkong Conlight Medical Group Limited | Tai Kok Tsui Hong Kong, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Biotest Biotech Co.,Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovation Scientific Pty Ltd | Vineyard New South Wales, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Disposables Corp | Orlando, FL, United States | Complaint file establishment, Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Jayamas Medica Industri TBK | Jombang Jawa Timur, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Biotech, LLC | Minneapolis, MN, United States | Complaint file establishment, Manufacturer for export, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prometheus Bio Inc. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao Hightop Biotech Co., Ltd. | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ucp Biosciences, Inc. | Milpitas, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivachek Biotech (hangzhou) Co., Ltd | Hangzhou, Zhuji Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W.H.P.M. Bioresearch & Technology Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W.H.P.M., Inc. | Irwindale, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 18, 2022. 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.