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
UO01S
Catalog number
UO01S
Device description
The LetsGetChecked Urine Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the primary containment and preservation of urine samples, for the purpose of in vitro diagnostic examination by our partner accredited laboratories.
Published
2022-03-30
Public version status
Update
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
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
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.

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
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
00810111410731Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal)PRIVAPATH DIAGNOSTICS LIMITEDQYA2026-04-15
00810111410748Simple 2 test (Simple 2 Urine Home Collection Kit (Penile))PRIVAPATH DIAGNOSTICS LIMITEDQYA2025-07-07
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