FDA.reportPublic FDA data

LetsGetChecked Blood Sample Collection Kit (BIOM2)

Primary DI
00850024881860
Brand
LetsGetChecked Blood Sample Collection Kit (BIOM2)
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
BO43S
Device description
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
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850024881860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024881860008500248818608500248818600850024881860

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection kit IVDA 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.

Regulatory Flags#

DUNS number
985578451
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111410748Simple 2 test (Simple 2 Urine Home Collection Kit (Penile))UO01S2025-07-07
00810111410731Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal)VS01S2026-04-15
00810111410847LetsGetChecked ImPressIMPRS2026-04-15
00810111410045LetsGetChecked Blood Sample Collection Kit (LIPP2)BO19SBO19S2025-07-07
00810111410281LetsGetChecked Blood Sample Collection Kit (PRGS)BO10SBO10S2025-07-07
00810111410335LetsGetChecked Blood Sample Collection Kit (TSTS)BO08S2025-07-07
00850024881846LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)UO03S2025-07-07
00850024881327LetsGetChecked Urine Sample Collection Kit (SM02)UO305, UO01SUO305, UO01S2022-03-30
00810111410212LetsGetChecked Blood Sample Collection Kit (MIC9)BO35SBO35S2023-07-28
00850024881976LetsGetChecked Blood Sample Collection Kit (GLCS) B026SB026S2023-01-16
00810111410014LetsGetChecked Blood Sample Collection Kit (FMHM)BO20SBO20S2022-09-30
00810111410175LetsGetChecked Blood Sample Collection Kit (MHTB)BO12SBO12S2022-09-30
00810111410342LetsGetChecked Blood Sample Collection Kit (TRFN) BO07SBO07S2022-09-30
00810111410090LetsGetChecked Blood Sample Collection Kit (HPTT) BO18SBO18S2022-10-03
00810111410106LetsGetChecked Blood Sample Collection Kit (HPSP)BO17SBO17S2022-07-01
00850024881310LetsGetChecked Blood Sample Collection Kit (MHTB)BO112, BO903, BO12SBO112, BO903, BO12S2022-04-05
00850024881471LetsGetChecked Blood Sample Collection Kit (TRFN)BO120, BO190BO120, BO1902022-04-05
00850024881020LetsGetChecked Blood Sample Collection Kit (FOLT)BO125BO1252022-04-01
00850024881594LetsGetChecked Blood Sample Collection Kit (TRFNUS+)BO06SBO06S2022-04-01
00860002028095LetsGetChecked Coronavirus (COVID-19) Home Sample Collection TestNO14S, NO15S, NO05S2023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220803BASELINE Venous Sample Collection kitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
00810010895011Aero-MedAERO-MED, LLCPQD2026-05-04
00810010894991Aero-MedAERO-MED, LLCPQD2026-04-07
00810010895004Aero-MedAERO-MED, LLCPQD2026-04-07
10885380211225Aero-MedAERO-MED, LLCPQD2026-03-20
50885380211223Aero-MedAERO-MED, LLCPQD2026-03-20
00850070635158KIT, BLOOD CULTURE COLLECTINGNar Medical Depot, LLCPQD2026-03-19
00810010894885Aero-MedAERO-MED, LLCPQD2026-03-17
50810010894880Aero-MedAERO-MED, LLCPQD2026-03-17
00810010894960Aero-MedAERO-MED, LLCPQD2026-03-17
00850066710272Simple HealthKitSIMPLE HEALTHKIT, INC.PQD2026-01-21
04779054721198RDA SpotRDA SPOT, UABPQD2026-01-15
00850015884351easycareSynchronis Medical, LLCPQD2026-01-07
00850015884368easycareSynchronis Medical, LLCPQD2026-01-07
04779054721129RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721143RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721082BLOODORDA SPOT, UABPQD2025-10-16
04779054721105BLOODORDA SPOT, UABPQD2025-10-16
04779054721112BLOODORDA SPOT, UABPQD2025-10-16
04779054721099BLOODORDA SPOT, UABPQD2025-10-13
04779054720276ZinzinoRDA SPOT, UABPQD2025-10-03
04779054720184ZinzinoRDA SPOT, UABPQD2025-09-16
04779054721013ZinzinoRDA SPOT, UABPQD2025-07-24
00810111410045LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07
00810111410281LetsGetChecked Blood Sample Collection Kit (PRGS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07
00810111410335LetsGetChecked Blood Sample Collection Kit (TSTS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07