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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

CountryMakers
United States35
China18
Germany2
United Kingdom2
Jordan1
Australia1
Indonesia1
Switzerland1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer3April 8, 2011000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer3May 15, 2001000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler2May 29, 2001000api.fda.gov
Alere San Diego, Inc.Pomona, CA, United StatesManufacturer, Manufacturer for export2April 20, 2021000api.fda.gov
Omega Laboratories, Inc.Mogadore, OH, United StatesManufacturer2June 25, 2013000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2January 27, 2000000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer1August 9, 2001000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1December 7, 1994000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesSpecification developer1August 9, 2001000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer1May 29, 2001000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1August 9, 2001000api.fda.gov
Lin-Zhi International, Inc.Santa Clara, CA, United StatesManufacturer1May 10, 2002000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer1September 28, 2000000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer1September 28, 2000000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1November 22, 2006000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1November 22, 2006000api.fda.gov
Phamatech Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler1February 4, 1998000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer1May 31, 1996000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer1May 31, 1996000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer1May 31, 1996000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer1January 10, 2005000api.fda.gov
Abon Biopharm (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer0000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Advin Biotech, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Ark Diagnostics IncFremont, CA, United StatesManufacturer for export0000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Atlas MedicalAmman Al 'Asimah, JordanManufacturer0000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Calbiotech, Inc.El Cajon, CA, United StatesManufacturer for export, Repackager or relabeler0000api.fda.gov
Co-Innovation Biotech Co.,ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Decheng Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Hangzhou Laihe Biotech Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hongkong Conlight Medical Group LimitedTai Kok Tsui Hong Kong, ChinaManufacturer, Specification developer0000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Biotest Biotech Co.,Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Innovation Scientific Pty LtdVineyard New South Wales, AustraliaContract manufacturer0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medical Disposables CorpOrlando, FL, United StatesComplaint file establishment, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer0000api.fda.gov
PT. Jayamas Medica Industri TBKJombang Jawa Timur, IndonesiaContract manufacturer0000api.fda.gov
Premier Biotech, LLCMinneapolis, MN, United StatesComplaint file establishment, Manufacturer for export, Specification developer0000api.fda.gov
Prometheus Bio Inc.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Qingdao Hightop Biotech Co., Ltd.Qingdao Shandong, ChinaManufacturer0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
Ucp Biosciences, Inc.Milpitas, CA, United StatesSpecification developer0000api.fda.gov
Vivachek Biotech (hangzhou) Co., LtdHangzhou, Zhuji Zhejiang, ChinaManufacturer0000api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer0000api.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.