FDA.reportPublic FDA data

Capillary blood collection kit IVD

Definition
A collection of in vitro diagnostic 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 container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.
GUDID devices
71
Last updated
2026-08-28 10:19:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04779054721273RDA SpotRDA SPOT, UABRS260092026-08-14
04779054721549PulsettoRDA SPOT, UABRS260432026-08-14
00810111410038LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDBO19S2026-08-07
00810111410052LetsGetChecked Blood Sample Collection Kit (HCV)PRIVAPATH DIAGNOSTICS LIMITEDBO36S2026-08-07
00810111410182LetsGetChecked Blood Sample Collection Kit (MHTP2)PRIVAPATH DIAGNOSTICS LIMITEDBO28S2026-08-07
00810111410205LetsGetChecked Blood Sample Collection Kit (MHTP)PRIVAPATH DIAGNOSTICS LIMITEDBO27S2026-08-07
00810111410250LetsGetChecked Blood Sample Collection Kit (ANMH2)PRIVAPATH DIAGNOSTICS LIMITEDBO11S2026-08-07
00810111410366LetsGetChecked Blood Sample Collection Kit (TRFNUS+)PRIVAPATH DIAGNOSTICS LIMITEDBO06S2026-08-07
00810111410540LetsGetChecked Blood Sample Collection Kit (GLCS)PRIVAPATH DIAGNOSTICS LIMITEDBO47S2026-08-07
00810111410557LetsGetChecked Blood Sample Collection Kit (LEAD)PRIVAPATH DIAGNOSTICS LIMITEDBO39S2026-08-07
00810111410588LetsGetChecked Blood Sample Collection Kit (HPSP)PRIVAPATH DIAGNOSTICS LIMITEDBO17S2026-08-07
00810111410649LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV)PRIVAPATH DIAGNOSTICS LIMITEDBO48S2026-08-07
00810111410694LetsGetChecked Blood Sample Collection Kit (EWB1)PRIVAPATH DIAGNOSTICS LIMITEDBO50S2026-08-07
00810111410700LetsGetChecked Blood Sample Collection Kit (EDB1)PRIVAPATH DIAGNOSTICS LIMITEDBO51S2026-08-07
00810111410793LetsGetChecked Blood Sample Collection Kit (KDRN)PRIVAPATH DIAGNOSTICS LIMITEDBO14S2026-08-07
00810111410816LetsGetChecked Blood Sample Collection Kit (CDST1)PRIVAPATH DIAGNOSTICS LIMITEDBO19S2026-08-07
00850024881877LetsGetChecked Blood Sample Collection Kit (BIOM)PRIVAPATH DIAGNOSTICS LIMITEDBO43S2026-08-07
00850024881884LetsGetChecked Blood Sample Collection Kit (BIOM4)PRIVAPATH DIAGNOSTICS LIMITEDBO46S2026-08-07
00850024881952LetsGetChecked Blood Sample Collection Kit (GLCSLIPP2)PRIVAPATH DIAGNOSTICS LIMITEDBO29S2026-08-07
00810111410045LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDBO19S2025-07-07
00810111410090LetsGetChecked Blood Sample Collection Kit (HPTT)PRIVAPATH DIAGNOSTICS LIMITEDBO18S2022-10-03
00810111410106LetsGetChecked Blood Sample Collection Kit (HPSP)PRIVAPATH DIAGNOSTICS LIMITEDBO17S2022-07-01
00810111410212LetsGetChecked Blood Sample Collection Kit (MIC9)PRIVAPATH DIAGNOSTICS LIMITEDBO35S2023-07-28
00850024881020LetsGetChecked Blood Sample Collection Kit (FOLT)PRIVAPATH DIAGNOSTICS LIMITEDBO1252022-04-01
00850024881310LetsGetChecked Blood Sample Collection Kit (MHTB)PRIVAPATH DIAGNOSTICS LIMITEDBO112, BO9032022-04-05
00850024881471LetsGetChecked Blood Sample Collection Kit (TRFN)PRIVAPATH DIAGNOSTICS LIMITEDBO120, BO1902022-04-05
00850024881594LetsGetChecked Blood Sample Collection Kit (TRFNUS+)PRIVAPATH DIAGNOSTICS LIMITEDBO06S2022-04-01
00850024881976LetsGetChecked Blood Sample Collection Kit (GLCS)PRIVAPATH DIAGNOSTICS LIMITEDB026S2023-01-16
00850024881860LetsGetChecked Blood Sample Collection Kit (BIOM2)PRIVAPATH DIAGNOSTICS LIMITEDBO43S2026-05-06
04779054720184ZinzinoRDA SPOT, UABRS250192025-09-16
04779054720276ZinzinoRDA SPOT, UABRS250212025-10-03
04779054721082BLOODORDA SPOT, UABRS250232025-10-16
04779054721099BLOODORDA SPOT, UABRS250222025-10-13
04779054721105BLOODORDA SPOT, UABRS250252025-10-16
04779054721112BLOODORDA SPOT, UABRS250242025-10-16
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDSCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDSCK107552026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDSCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDSCK107962026-05-22
04779054721198RDA SpotRDA SPOT, UABRS260012026-01-15
04779054721129RDA SpotRDA SPOT, UABRS250292025-11-20
04779054721143RDA SpotRDA SPOT, UABRS250282025-11-20
04779054721013ZinzinoRDA SPOT, UABRS250122025-07-24
00810111410281LetsGetChecked Blood Sample Collection Kit (PRGS)PRIVAPATH DIAGNOSTICS LIMITEDBO10S2025-07-07
00810111410335LetsGetChecked Blood Sample Collection Kit (TSTS)PRIVAPATH DIAGNOSTICS LIMITEDBO08S2025-07-07
04779054720122ZinzinoRDA SPOT, UABBT12024-12-27
04779054720412ZinzinoRDA SPOT, UABBT22024-12-27
20860013131238Medzah Kidney Health Combo Collection KitMedzah IndustriesMDZHKHC012024-11-25
04779054720863Young GooseRDA SPOT, UABRS240042024-10-22
04779054720726National labsRDA SPOT, UABRS240032024-09-06
00810040820984Heart Health + Cholesterol TestCue Health Inc.C22242024-04-30
00810040820991Vitamin D TestCue Health Inc.C22322024-04-30
00810040821004Kidney Function TestCue Health Inc.C22362024-04-30
00810040821011Men's Health TestCue Health Inc.C22452024-04-30
00810040821028Heart Disease Risk Test: Lipoprotein a + ApoBCue Health Inc.C22252024-04-30
00810040821035Glucose + Insulin TestCue Health Inc.C22462024-04-30
00810040821103Food Sensitivity TestCue Health Inc.C22342024-04-30
00810040821059Women's Health TestCue Health Inc.C22262024-04-12
00810040821066Fertility Test for WomenCue Health Inc.C22272024-04-12
00810040821080Liver Function TestCue Health Inc.C22332024-04-12
00810040821042Celiac Disease TestCue Health Inc.C22472024-03-11
00810040821110HIV TestCue Health Inc.C22492024-03-11
00810040821127Hepatitis C TestCue Health Inc.C22502024-03-11
00810040821141Thyroid TestCue Health Inc.C22512024-03-11
00810040821158Food Allergy TestCue Health Inc.C22522024-03-11
00810040821165Indoor + Outdoor Allergy TestCue Health Inc.C22532024-03-11
00810040821202Premium Heart Health + Cholesterol TestCue Health Inc.C22562024-03-11
00810040821073Herpes TestCue Health Inc.C22312024-02-12
00810040821097Heart Health + Metabolic TestCue Health Inc.C22482024-02-12
00860010959244US Biotek LaboratoriesU.S. Biotek Laboratories LLC1.02023-09-15
00860010987803Enable Blood Spot Collection KitEnable Biosciences Inc.EBCK12023-09-14