FDA.reportPublic FDA data

SNT Biotech

Primary DI
00810057230417
Brand
SNT Biotech
Company
SARIS AND THINGS, INC.
Model
SNT-OCAUTO-001
Catalog number
SNT-OCAUTO
Device description
STOOL COLLECTION KIT FOR FECAL IMMUNOCHEMICAL TEST (FIT)
Published
2024-07-29
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
00810057230417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810057230417008100572304178100572304170810057230417

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058264894
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810057230448SNT BiotechSNT-KED-W-01SNTKED012026-06-04
00810057230424SNT BiotechSNT-ADX100-001SNT-ADX1002024-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20885380008761CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380008785CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380036467CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380073714CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380084451CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380169004CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
00810111410861LetsGetChecked Stool Sample Collection Kit (FCIT)PRIVAPATH DIAGNOSTICS LIMITEDNNK2026-08-07
04038917581882Salivette®Sarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PPSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055837Screw cap, pastel-greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055998Screw cap, pastel-orangeSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056049Screw cap, pastel-violetSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056148Screw cap, pastel-yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056407Screw cap, pastel-blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057831SafeSeal tube 0.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057879SafeSeal tube 0.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058012SafeSeal tube 0.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058050SafeSeal tube 0.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058135SafeSeal tube 0.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058173SafeSeal tube 0.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058210Micro tube 0.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058296SafeSeal tube 1.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058340SafeSeal tube 1.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058388SafeSeal tube 1.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058425SafeSeal tube 1.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058463SafeSeal tube 1.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058500SafeSeal tube 1.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058548Micro tube 1.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916059354Faeces tube 101x16.5mmSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
00840216129290Quest DiagnosticsAsp Global, LLCNNK2026-07-17