FDA.reportPublic FDA data

LetsGetChecked Urine Sample Collection Kit (SM02)

Primary DI
00850024881327
Brand
LetsGetChecked Urine Sample Collection Kit (SM02)
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
UO305, UO01S
Catalog number
UO305, UO01S
Device description
A collection of noninvasive devices intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation.
Published
2022-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIEUrine Collection Kit (Excludes Hiv Testing)
QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIEUrine Collection Kit (Excludes Hiv Testing)Pathology1
QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At HomeMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850024881327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024881327008500248813278500248813270850024881327

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00850024881860LetsGetChecked Blood Sample Collection Kit (BIOM2)BO43S2026-05-06
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
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
00810111410731Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal)PRIVAPATH DIAGNOSTICS LIMITEDQYA2026-04-15
10809160518397MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OIE2026-04-07
50382903649346BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-02-03
00382903649341BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-02-03
19120126131407VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131414VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131421VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131469VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131404VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131411VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131428VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131466VACUETTEGreiner Bio-One GmbHOIE2026-01-26
50382903649322BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
00382903649327BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
00810185250547TherapakTherapak LLCOIE2025-08-11
00810185250554TherapakTherapak LLCOIE2025-08-11
00810111410748Simple 2 test (Simple 2 Urine Home Collection Kit (Penile))PRIVAPATH DIAGNOSTICS LIMITEDQYA2025-07-07
00850024881846LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)PRIVAPATH DIAGNOSTICS LIMITEDOIE2025-07-07
00884999051348simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
00884999051409simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
30884999051349simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
30884999051400simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
00840117338029LabChoice Midstream Specimen Catch Kit, SterileDynarex CorporationOIE2025-03-14
00860013362904RTL Urine Collection KitRealtime Laboratories, Inc.OIE2025-02-28
G7327021Everlywell Blood and Urine Collection KitEverly Health, Inc.OIE2025-02-18
G7324001Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
G7324011Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
10860009616032Kidney Stone Transportation KitDitek Consulting, LLCOIE2024-11-19
05055273220018PlaySafe™ RANDOX LABORATORIES LIMITEDOIE2024-10-01
00850054552051US Urine Examiner KitQuest DiagnosticsOIE2024-05-01