FDA.reportPublic FDA data

Capillary blood collection kit, home-use

Definition
A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.
GUDID devices
23
Last updated
2025-02-24 08:56:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
G7321001Everlywell Blood Collection KitEverly Health, Inc.32025-02-14
G7321011Everlywell Blood Collection KitEverly Health, Inc.32025-02-14
G7321021Everlywell Blood Collection KitEverly Health, Inc.12025-02-14
G7321031Everlywell Blood Collection KitEverly Health, Inc.22025-02-14
G7321041Everlywell Blood Collection KitEverly Health, Inc.22025-02-14
G7321061Everlywell Blood Collection KitEverly Health, Inc.32025-02-14
G7321071Everlywell Blood Collection KitEverly Health, Inc.32025-02-14
G7321081Everlywell Blood Collection KitEverly Health, Inc.12025-02-14
G7321091Everlywell Blood Collection KitEverly Health, Inc.42025-02-14
G7322001Everlywell Blood Collection KitEverly Health, Inc.32025-02-14
G7322011Everlywell Blood Collection KitEverly Health, Inc.32025-02-14
G7322021Everlywell Blood Collection KitEverly Health, Inc.32025-02-14
G7327001Everlywell Blood and Saliva Collection KitEverly Health, Inc.22025-02-14
G7327031Everlywell Blood and Saliva Collection KitEverly Health, Inc.42025-02-14
04779054720108RDA SpotRDA SPOT, UABRDA0012024-01-23
06974567745800EMSRUNWuxi Emsrun Technology Co., Ltd.PZQJ00022023-05-29
00810094575854CuraplexBOUND TREE MEDICAL, LLC680152-KIT2023-04-30
06974567741116EMSRUNWuxi Emsrun Technology Co., Ltd.PZJE00022022-12-02
06974567741147EMSRUNWuxi Emsrun Technology Co., Ltd.PZSI00082022-12-02
06974567742632EMSRUNWuxi Emsrun Technology Co., Ltd.PZSI00062022-12-02
06974567742649EMSRUNWuxi Emsrun Technology Co., Ltd.PZQJ00012022-12-02
00850032976107Truepill Inc.Postmeds, Inc.12022-03-07
M769HIVSTANDARD211HIV-1 Standard Test SystemHome Access Health Corporation212015-09-03