FDA.reportPublic FDA data

LetsGetChecked Stool Sample Collection Kit

Primary DI
00850024881259
Brand
LetsGetChecked Stool Sample Collection Kit
Company
PRIVAPATH DIAGNOSTICS LIMITED
Model
FT01S, FT102, FT101
Catalog number
FT01S, FT102, FT101
Device description
A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory.
Published
2022-05-04
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
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850024881259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024881259008500248812598500248812590850024881259

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen collection kit IVD, home-useA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00827989007772Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007796Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
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00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
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