Data / Medical devices / Blood Specimen Collection Convenience Kit (Excludes Hiv)
Blood Specimen Collection Convenience Kit (Excludes Hiv) (PQD): 39 FDA-registered makers in 9 countries
39 establishments in 9 countries are registered with the FDA to make Blood Specimen Collection Convenience Kit (Excludes Hiv) (product code PQD, Class 2, 21 CFR 862.1675). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- PQD
- Device class
- 2
- Regulation
- 862.1675
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 29 |
| Mexico | 2 |
| United Kingdom | 2 |
| Canada | 1 |
| India | 1 |
| Singapore | 1 |
| Ireland | 1 |
| Lithuania | 1 |
| China | 1 |
Makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
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 |
|---|---|---|---|---|---|---|---|---|
| Aero-Med LLC | East Hartford, CT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ALOM Technologies Corporation | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biodesix, Inc. | Louisville, CO, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Disruptive Medtech, LLC | Laramie, WY, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enable Biosciences | South San Francisco, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Everly Health, Inc. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Generation Lab | Burlingame, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genetrack Biolabs Inc. | Vancouver British Columbia, Canada | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| IMPILO, Inc. | Philadelphia, PA, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ixlayer | San Francisco, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Impilo Phoenix | Phoenix, AZ, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kit Company | Phoenix, AZ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kryocall LLC Dba Kryosphere | Cary, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labcorp Genetics | San Francisco, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MHC Health Management Solutions, LLC | Cape Coral, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NAR Medical Depot, LLC | Greer, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neelyx Labs | Wood Dale, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NSP Tech Pte Ltd | Singapore Central Singapore, Singapore | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision For Medicine | Frederick, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Privapath Diagnostics Ltd | Dublin 11 Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories-Us, Ltd | Kearneysville, WV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Renalytixai | Long Island City, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roman Health Ventures Inc. | New York, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley Global Turnkey Solutions | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectrum Solutions LLC | Draper, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spot Health Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supera Fulfillment LLC | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synchronis Medical LLC | Romulus, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tasso Inc | Seattle, WA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Dot Printer Inc. | Irvine, CA, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Rda Spot | Vilnius, Lithuania | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vericel Corporation | Cambridge, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.