FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810057230417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810057230417008100572304178100572304170810057230417

GMDN Terms

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

Regulatory Flags

DUNS number
058264894
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810057230424SNT BiotechSNT-ADX100-001SNT-ADX1002024-07-29

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