First Diagnostic Corporation develops rapid point-of-care diagnostic systems and helps other medical-device manufacturers bring diagnostic technologies to the U.S. healthcare market. Founded in 2004 as a medical-device manufacturer, the privately held company now combines its own rapid-test brands with sales representation, distribution, marketing, and customer support for partner manufacturers. Its eight-person operation maintains government and military program relationships and cites GMP and ISO 9001 quality standards.
GMP
ISO-9001
ISO 1345:2003
Fed Gov CCR/SAM CAGE Code 7GSK6
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EIN 47-5259687
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Colorado Document Number 20151653178
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NAICS 325413 In-Vitro Diagnostic Substance Manufacturing
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SIC 2835 In Vitro and In Vivo Diagnostic Substances
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FSC 6550 In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
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Chembio Diagnostic Systems, IncChembio Diagnostic Systems, a Medford, New York subsidiary of Biosynex, develops and manufactures rapid point-of-care diagnostic tests for detecting and monitoring disease. Its proprietary Dual Path Platform (DPP®) technology supports simple tests that can use a small blood sample and deliver results in about 15 minutes, including the FDA-approved, CLIA-waived DPP® HIV-Syphilis test. Chembio serves clients worldwide through offices and partners and also applies its diagnostic platform to veterinary testing.MEDFORD, NY
Novel Microdevices, IncBaltimore-based Novel Microdevices develops portable, sample-to-answer molecular diagnostic systems built around disposable microfluidic cartridges. Its battery-powered Novel Dx platform is designed to deliver lab-quality PCR results in about 15 minutes, including testing for respiratory infections and other diseases at the point of care. The company is establishing a GMP-compliant pilot manufacturing facility at its Baltimore headquarters to scale cartridge production.BALTIMORE, MD
Prompt DiagnosticsBaltimore-based Prompt Diagnostics develops portable molecular diagnostic platforms that bring laboratory-quality PCR testing to the point of care, with results in under 20 minutes. Co-founded by biomedical engineer Alex Trick and Johns Hopkins professor Tza-Huei (Jeff) Wang, the company built its platform around magnetofluidic cartridge technology invented during Trick’s doctoral research. Prompt is applying that technology to infectious-disease testing, including work on HIV, syphilis, and drug-resistant gonorrhea in low-resource settings.BALTIMORE, MD
Maxim Biomedical, IncFrom its Rockville, Maryland facility, Maxim Biomedical develops and manufactures diagnostic tests while helping healthcare companies and government agencies move assays from concept to commercial production. Founded more than 20 years ago, the family-led company produces millions of tests each month in an FDA-registered, ISO 13485:2016-certified operation with capacity exceeding 15 million devices monthly. Its own products include HIV surveillance assays and the ClearDetect COVID-19 Antigen Home Test, alongside contract development and manufacturing for partners worldwide.ROCKVILLE, MD