Updated 22 October 2026
In-vitro diagnostics distributors in the United States: 1,354 licensed establishments
The Bastion Hale Distributor Index lists 1,354 establishments in the United States whose registry records include in-vitro diagnostics: 22 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 441 manufacturers' own import or sales entities, 0 regulatory representatives, and 891 manufacturers or exporters, out of 10,187 medical device establishments in the United States overall. The records come from US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 444 | 33% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 57 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 239 | 18% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 1,313 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 195 | 14% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in the United States
In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.
Top 20 independent in-vitro diagnostics distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Celllab International, Llc Wyomissing, PA | Distributor Importer, Distributor | In-vitro diagnostics | 1 | 2 | 0 | 24.0 | 3/5 |
| 2 | MICRO DIRECT, INC. LEWISTON, ME | Distributor Importer, Distributor | Anaesthesia and respiratory, In-vitro diagnostics | 1 | 2 | 0 | 24.0 | 3/5 |
| 3 | MERCEDES MEDICAL LLC Lakewood Ranch, FL | Distributor Importer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 76 | 1 | 0 | 34.9 | 3/5 |
| 4 | JANT PHARMACAL CORP. ENCINO, CA | Distributor Importer | Cardiovascular, Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 59 | 1 | 0 | 33.7 | 3/5 |
| 5 | FORA CARE INC. Moorpark, CA | Distributor Importer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 43 | 1 | 0 | 32.1 | 3/5 |
| 6 | Prime Med Shop LLC Stafford, TX | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +2 more | 31 | 1 | 0 | 30.5 | 3/5 |
| 7 | HOME HEALTH US INCORPORATED Sarasota, FL | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +1 more | 25 | 1 | 0 | 29.4 | 3/5 |
| 8 | PRODIGY DIABETES CARE, LLC Huntersville, NC | Distributor Importer | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +2 more | 19 | 1 | 0 | 28.1 | 3/5 |
| 9 | PHARMA SUPPLY, INC. Wellington, FL | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +2 more | 15 | 1 | 0 | 27.0 | 3/5 |
| 10 | Alius Scientific,LLC Carolina, PR | Distributor Importer | In-vitro diagnostics | 12 | 1 | 0 | 25.9 | 3/5 |
| 11 | METIER MEDICAL (USA) LLC Ponte Vedra Beach, FL | Distributor Importer | General hospital and consumables, In-vitro diagnostics | 12 | 1 | 0 | 25.9 | 3/5 |
| 12 | THORACENT LLC Huntington, NY | Distributor Importer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics, Surgery and endoscopy | 11 | 1 | 0 | 25.5 | 3/5 |
| 13 | LetsGetChecked Inc City View Heights, OH | Distributor Importer | General hospital and consumables, In-vitro diagnostics, Surgery and endoscopy | 10 | 1 | 0 | 25.1 | 3/5 |
| 14 | LIFE PRP Dallas, TX | Distributor Importer | Aesthetics, dermatology and lasers, In-vitro diagnostics, Patient monitoring and neurology +1 more | 8 | 1 | 0 | 24.1 | 3/5 |
| 15 | 2SAN LLC New York, NY | Distributor Importer | In-vitro diagnostics | 7 | 1 | 0 | 23.5 | 3/5 |
| 16 | Lusis Biosciences, Inc. Hayward, CA | Distributor Importer | In-vitro diagnostics | 4 | 1 | 0 | 21.1 | 3/5 |
| 17 | WICKI MEDICAL, LLC Pittsburgh, PA | Distributor Importer | Aesthetics, dermatology and lasers, In-vitro diagnostics, Surgery and endoscopy | 4 | 1 | 0 | 21.1 | 3/5 |
| 18 | LERAISE HEALTH INTERNATIONAL LLC Dover, DE | Distributor Importer | Cardiovascular, In-vitro diagnostics | 3 | 1 | 0 | 20.0 | 3/5 |
| 19 | ISHIDA MEDICAL LLC Irvine, CA | Distributor Importer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 2 | 1 | 0 | 18.5 | 3/5 |
| 20 | VELA DIAGNOSTICS USA, INC Fairfield, NJ | Distributor Importer | In-vitro diagnostics | 2 | 1 | 0 | 18.5 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (1,332)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Siemens Healthcare Diagnostics, Inc. E Walpole, MA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +2 more | 1527 | 894 | 0 | 80.6 | 3/5 |
| 2 | Boston Scientific Corporation Coventry, RI | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1196 | 520 | 0 | 80.6 | 3/5 |
| 3 | Covidien LLC North Haven, CT | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 959 | 454 | 0 | 80.4 | 3/5 |
| 4 | ICU Medical, Inc. SOUTHINGTON, CT | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1023 | 353 | 0 | 79.3 | 3/5 |
| 5 | Abbott Medical PLANO, TX | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 619 | 299 | 1 | 80.8 | 4/5 |
| 6 | HOLOGIC, INC. Marlborough, MA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +6 more | 305 | 245 | 0 | 74.6 | 3/5 |
| 7 | BIOCARE MEDICAL, LLC Pacheco, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | In-vitro diagnostics | 180 | 234 | 1 | 74.6 | 4/5 |
| 8 | Conmed Corporation WESTBOROUGH, MA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 911 | 222 | 0 | 80.1 | 3/5 |
| 9 | Becton, DIckinson and Company Cockeysville, MD | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 693 | 204 | 1 | 81.4 | 4/5 |
| 10 | Microgenics Corporation Fremont, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, Dental, Ear, nose and throat +1 more | 298 | 204 | 1 | 77.1 | 4/5 |
| 11 | COOK, INCORPORATED ELLETTSVILLE, IN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 791 | 202 | 0 | 79.4 | 3/5 |
| 12 | MERIT MEDICAL SYSTEMS, INC. South Jordan, UT | Maker's own entity Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 537 | 199 | 0 | 77.4 | 3/5 |
| 13 | INOVA DIAGNOSTICS, INC. SAN DIEGO, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics | 220 | 194 | 0 | 72.8 | 3/5 |
| 14 | BECKMAN COULTER, INC. HIALEAH, FL | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Ear, nose and throat +3 more | 750 | 151 | 0 | 77.8 | 3/5 |
| 15 | Bausch & Lomb Incorporated Manchester, MO | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 637 | 151 | 0 | 77.0 | 3/5 |
| 16 | Agilent Technologies, Inc. Winooski, VT | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 172 | 145 | 0 | 70.2 | 3/5 |
| 17 | Bio-Rad Laboratories, Inc. IRVINE, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology +1 more | 373 | 143 | 0 | 74.0 | 3/5 |
| 18 | INSTRUMENTATION LABORATORY CO. Bedford, MA | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 177 | 121 | 0 | 70.5 | 3/5 |
| 19 | Teleflex Medical Inc. Morrisville, NC | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 858 | 114 | 1 | 78.6 | 4/5 |
| 20 | ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI | Maker's own entity Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 767 | 113 | 0 | 75.3 | 3/5 |
Questions about in-vitro diagnostics distributors in the United States
How many in-vitro diagnostics distributors are there in the United States?
The Index counts 1,354 establishments in the United States with in-vitro diagnostics in their registry record, of which 22 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics device registration in the United States?
In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.
How do I find a in-vitro diagnostics distributor in the United States?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and the United States to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a in-vitro diagnostics distributor in the United States?
A company that appears in a public regulatory registry with an address in the United States and whose linked device listings fall in the in-vitro diagnostics segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in the United States
In-vitro diagnostics in other North America markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 1,335 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 303 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 281 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.