FDA.reportPublic FDA data

LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)

Primary DI
00850024881846
Brand
LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
UO03S
Device description
A 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.
Published
2025-07-07
Public version status
New
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)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIEUrine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850024881846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024881846008500248818468500248818460850024881846

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
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
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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
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10860009616032Kidney Stone Transportation KitDitek Consulting, LLCOIE2024-11-19
05055273220018PlaySafe™ RANDOX LABORATORIES LIMITEDOIE2024-10-01
00850054552051US Urine Examiner KitQuest DiagnosticsOIE2024-05-01
10850054552058US Urine Examiner KitQuest DiagnosticsOIE2024-05-01
04580455980851Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
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00810113420028INDICAID health Sexual Health 2Phase Diagnostics, Inc.OIE2023-10-03
00860010959206US Biotek LaboratoriesU.S. Biotek Laboratories LLCOIE2023-09-15
00810040820625Cue Sample Collection Kit Cue Health Inc.OIE2023-02-27
00860193001761UroMap Specimen Collection KitCAREDX, INC.OIE2023-02-10