FDA.report

SNT Biotech

Primary DI
00810057230424
Brand
SNT Biotech
Company
SARIS AND THINGS, INC.
Model
SNT-ADX100-001
Catalog number
SNT-ADX100
Device description
DRIED BLOOD SPOT COLLECTION KIT (ADX)
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
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Product Code Classifications

CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810057230424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810057230424008100572304248100572304240810057230424

GMDN Terms

TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

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
00810057230417SNT BiotechSNT-OCAUTO-001SNT-OCAUTO2024-07-29

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