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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.

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Product code
PQD
Device class
2
Regulation
862.1675
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States29
Mexico2
United Kingdom2
Canada1
India1
Singapore1
Ireland1
Lithuania1
China1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aero-Med LLCEast Hartford, CT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
ALOM Technologies CorporationIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Biodesix, Inc.Louisville, CO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Cardinal Health 200, LLCEl Paso, TX, United StatesManufacturer0000api.fda.gov
Convertors de Mexico S. de R.L. de C.VCD.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
Disruptive Medtech, LLCLaramie, WY, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Enable BiosciencesSouth San Francisco, CA, United StatesSpecification developer0000api.fda.gov
Everly Health, Inc.Austin, TX, United StatesManufacturer0000api.fda.gov
Generation LabBurlingame, CA, United StatesManufacturer0000api.fda.gov
Genetrack Biolabs Inc.Vancouver British Columbia, CanadaContract manufacturer, Repackager or relabeler0000api.fda.gov
IMPILO, Inc.Philadelphia, PA, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
IxlayerSan Francisco, CA, United StatesSpecification developer0000api.fda.gov
Impilo PhoenixPhoenix, AZ, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Kit CompanyPhoenix, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Kryocall LLC Dba KryosphereCary, NC, United StatesManufacturer0000api.fda.gov
Labcorp GeneticsSan Francisco, CA, United StatesSpecification developer0000api.fda.gov
Mark EnterprisesNashik Maharashtra, IndiaManufacturer0000api.fda.gov
MHC Health Management Solutions, LLCCape Coral, FL, United StatesSpecification developer0000api.fda.gov
NAR Medical Depot, LLCGreer, SC, United StatesManufacturer0000api.fda.gov
Neelyx LabsWood Dale, IL, United StatesManufacturer0000api.fda.gov
NSP Tech Pte LtdSingapore Central Singapore, SingaporeManufacturer0000api.fda.gov
Precision For MedicineFrederick, MD, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Privapath Diagnostics LtdDublin 11 Dublin(County), IrelandManufacturer0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomSpecification developer0000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomSpecification developer0000api.fda.gov
Randox Laboratories-Us, LtdKearneysville, WV, United StatesManufacturer0000api.fda.gov
RenalytixaiLong Island City, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Roman Health Ventures Inc.New York, NY, United StatesSpecification developer0000api.fda.gov
RR Donnelley Global Turnkey SolutionsJuarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Spectrum Solutions LLCDraper, UT, United StatesContract manufacturer0000api.fda.gov
Spot Health Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Supera Fulfillment LLCHouston, TX, United StatesManufacturer0000api.fda.gov
Synchronis Medical LLCRomulus, MI, United StatesManufacturer0000api.fda.gov
Tasso IncSeattle, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
The Dot Printer Inc.Irvine, CA, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
UAB Rda SpotVilnius, LithuaniaManufacturer0000api.fda.gov
Vericel CorporationCambridge, MA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Zhejiang Gongdong Medical Technology Co., LtdTAIZHOU Zhejiang, ChinaManufacturer0000api.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.