SCI Medic, Inc. develops and supplies FDA-cleared home diagnostic devices and over-the-counter consumer health products, with a particular focus on pregnancy, ovulation, drug and urinary-tract testing. The company also builds private-label and control-branded programs for retailers, distributors and healthcare organizations across the United States and Canada, taking projects from product development through packaging and fulfillment. Its FDA-established facility follows 21 CFR 820 regulations and holds ISO 13485:2016 certification, while the company is certified by WBENC as a women’s business enterprise.
FDA Established Facility following 21 CFR 820 Medical Device Regulations
Compliance program
WBENC National Women's Business Enterprise Certification
ISO 13485:2016 Certification
FDA Registered
Registration
FDA Cleared Products
Registration
21CFRPART820
Quality certification
FDA
Quality certification
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
NIKOMED USASince 1986, NIKOMED USA has independently supplied medical devices and healthcare products, with a particular focus on ECG electrodes and related diagnostic solutions. The company also develops private-label programs for distributors and OEMs, pairing its catalog with product expertise and responsive, hands-on support. NIKOMED is ISO 13485:2016 certified, FDA registered, and Health Canada registered.HATBORO, PA
First Diagnostic CorporationFirst 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.NEW YORK, NY
OSMedTechOSMedTech develops and manufactures respiratory diagnostic solutions, with a focus on multiplex testing for over-the-counter and point-of-care use. Its facility includes three GMP-grade clean rooms and two automated production lines, supporting stated monthly capacity of 300 million lateral-flow assay units. The Cleveland-based company is designing the platform for U.S. manufacturing and domestic supply-chain resiliency.CHAGRIN FALLS, OH