FDA.reportPublic FDA data

LetsGetChecked Blood and Urine Sample Collection Kit (ST04)

Primary DI
00810111410533
Brand
LetsGetChecked Blood and Urine Sample Collection Kit (ST04)
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
BU09S
Catalog number
BU09S
Device description
The LetsGetChecked Blood and Urine Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of blood and urine samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111410533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111410533008101114105338101114105330810111410533

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, home-useA collection of devices intended to be used by a layperson in the home for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula, cup], and a covered specimen receptacle(s) with or without an additive/medium (e.g., preservation solution, microbiological medium) and mailing packing/envelope. It may include other relevant devices (e.g., a lancet). This is a single-use device.

Regulatory Flags#

DUNS number
985578451
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111410038LetsGetChecked Blood Sample Collection Kit (LIPP2)BO19SBO19S2026-08-07
00810111410052LetsGetChecked Blood Sample Collection Kit (HCV)BO36SBO36S2026-08-07
00810111410182LetsGetChecked Blood Sample Collection Kit (MHTP2)BO28SBO28S2026-08-07
00810111410199LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC)BS01SBS01S2026-08-07
00810111410205LetsGetChecked Blood Sample Collection Kit (MHTP)BO27SBO27S2026-08-07
00810111410250LetsGetChecked Blood Sample Collection Kit (ANMH2)BO11SBO11S2026-08-07
00810111410366LetsGetChecked Blood Sample Collection Kit (TRFNUS+)BO06SBO06S2026-08-07
00810111410540LetsGetChecked Blood Sample Collection Kit (GLCS)BO47SBO47S2026-08-07
00810111410557LetsGetChecked Blood Sample Collection Kit (LEAD)BO39SBO39S2026-08-07
00810111410588LetsGetChecked Blood Sample Collection Kit (HPSP)BO17SBO17S2026-08-07
00810111410601LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED)BU08SBU08S2026-08-07
00810111410649LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV)BO48SBO48S2026-08-07
00810111410663LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2)BU11SBU11S2026-08-07
00810111410670LetsGetChecked Vaginal HPV Sample Collection Kit (HPVT & HPVT2)VS01SVS01S2026-08-07
00810111410694LetsGetChecked Blood Sample Collection Kit (EWB1)BO50SBO50S2026-08-07
00810111410700LetsGetChecked Blood Sample Collection Kit (EDB1)BO51SBO51S2026-08-07
00810111410724LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C)BU06SBU06S2026-08-07
00810111410793LetsGetChecked Blood Sample Collection Kit (KDRN)BO14SBO14S2026-08-07
00810111410809LetsGetChecked Blood and Urine Sample Collection Kit (ST05)BU04SBU04S2026-08-07
00810111410816LetsGetChecked Blood Sample Collection Kit (CDST1)BO19SBO19S2026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111410601LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410663LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410724LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
00810111410809LetsGetChecked Blood and Urine Sample Collection Kit (ST05)PRIVAPATH DIAGNOSTICS LIMITEDOIB2026-08-07
10885380210891Aero-MedAERO-MED, LLCOIB2026-06-10
10885380213465Aero-MedAERO-MED, LLCOIB2026-06-10
00810057230448SNT BiotechSARIS AND THINGS, INC.OIB2026-06-04
10885380212017Aero-MedAERO-MED, LLCOIB2026-06-04
10885380212024Aero-MedAERO-MED, LLCOIB2026-06-04
10885380211768Aero-MedAERO-MED, LLCOIB2026-05-06
10192253071504Aero-MedAERO-MED, LLCOIB2026-04-16
10192253061031Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061093Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061109Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061475Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061482Aero-MedAERO-MED, LLCOIB2026-02-20
10192253061505Aero-MedAERO-MED, LLCOIB2026-02-20
10885380211188Aero-MedAERO-MED, LLCOIB2026-02-13
10885380210921Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210938Aero-MedAERO-MED, LLCOIB2026-01-20
10885380210877Aero-MedAERO-MED, LLCOIB2025-12-26
10885380208935Aero-MedAERO-MED, LLCOIB2025-11-04
10885380209222Aero-MedAERO-MED, LLCOIB2025-08-26
10885380208928Aero-MedAERO-MED, LLCOIB2025-08-21
10885380208447Aero-MedAERO-MED, LLCOIB2025-06-10
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10885380203657Aero-MedAERO-MED, LLCOIB2024-08-01
10885380203664Aero-MedAERO-MED, LLCOIB2024-08-01
10194717119739Regard™ROI CPS, LLCOIB2024-07-19