FDA.reportPublic FDA data

Simple 2 test (Simple 2 Urine Home Collection Kit (Penile))

Primary DI
00810111410748
Brand
Simple 2 test (Simple 2 Urine Home Collection Kit (Penile))
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
UO01S
Device description
The Simple 2 Test is intended for in vitro detection and identification of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home-collected specimens which are shipped to a clinical laboratory for testing using the Aptima Combo 2 Assay on the Panther System. This product is available over-the-counter (OTC) to consumers 18 years of age and older. The Simple 2 Test contains all the necessary components to collect urine from male patients (Simple 2 Urine Home Collection Kit (Penile)) or vaginal swabs from female patients (Simple 2 Swab Home Collection Kit (Vaginal)) in their home, or in similar environments, without supervision from a healthcare provider. The Simple 2 Test Collection Kits may also be used to self-collect specimens in a clinic. The testing is performed, as determined to be appropriate, based on the results of LetsGetChecked Suitability Questionnaire. This test system is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider. Testing is limited to the manufacturer, Priva Path laboratories (d.b.a. LetsGetChecked, Inc.).
Published
2025-07-07
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
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
00810111410748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111410748008101114107488101114107480810111410748

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
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
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
00810111410731Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal)PRIVAPATH DIAGNOSTICS LIMITEDQYA2026-04-15
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
00850024881327LetsGetChecked Urine Sample Collection Kit (SM02)PRIVAPATH DIAGNOSTICS LIMITEDQYA2022-03-30