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
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
00810111410533LetsGetChecked Blood and Urine Sample Collection Kit (ST04)BU09SBU09S2026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528068MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OIE2026-07-29
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
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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
10850054552058US Urine Examiner KitQuest DiagnosticsOIE2024-05-01
04580455980851Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
04580455981025Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
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