FDA.reportPublic FDA data

SNT Biotech

Primary DI
16973471969866
Brand
SNT Biotech
Company
Shenzhen Dakewe Bio-engineering Co., Ltd
Model
OP
Device description
Oropharyngeal swab.
Published
2024-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26973471969863PackageGS155In Commercial Distribution
06973471960750PreviousGS10
16973471969866PrimaryGS10
06973471969869Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697347196986326973471969863
06973471960750069734719607506973471960750
1697347196986616973471969866
06973471969869069734719698696973471969869

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection swabA piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.

Regulatory Flags#

DUNS number
543029175
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16973471962171BioSciON2026-05-08
16973471962188BioSciON2026-05-08
16973471962195BioSciOO2026-05-08
16973471962201BioSciOO2026-05-08
16973471962218BioSciONO2026-05-08
16973471962225BioSciONO2026-05-08
16973471962232BioSciOM2026-05-08
16973471962249BioSciOM2026-05-08
16973471962256BioSciOM2026-05-08
16973471962263BioSciOM2026-05-08
16977644780029BioSci™VO69913212024-08-30
16977644780036BioSci™VNO69911912024-08-30
16977644780043BioSci™VNO69913912024-08-30
26977644780026BioSci™VO69913212024-08-30
26977644780033BioSci™VNO69911912024-08-30
26977644780040BioSci™VNO69913912024-08-30
16977644780012BioSci™VO69911212024-08-12
26977644780019BioSci™VO69911212024-08-12
16973471969941BioSci™VM69910142024-07-23
16973471969996BioSci™VN69911112024-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971893320473Disposable Sampling SwabMIRACLEAN TECHNOLOGY CO., LTD.KXG2026-08-26
06971893320794Disposable Sampling SwabMIRACLEAN TECHNOLOGY CO., LTD.KXG2026-08-26
00609576381164Puritan®Puritan Medical ProductsKXG2026-07-31
10609576901789QuickVuePuritan Medical ProductsKXG2026-07-31
30609576380618Hospital®Puritan Medical ProductsKXG2026-07-31
00609576381119Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381133Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381423Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381676Puritan®Puritan Medical ProductsKXG2026-07-27
00609576901799Puritan®Puritan Medical ProductsKXG2026-07-27
30609576381196Puritan®Puritan Medical ProductsKXG2026-07-27
30609576380601Hospital®Puritan Medical ProductsKXG2026-07-20
30609576380809Puritan®Puritan Medical ProductsKXG2026-07-20
50609576901701cobas Dual SwabsPuritan Medical ProductsKXG2026-07-20
00810124537616VaklyAvaline Medical NJ Limited Liability CompanyKXG2026-07-16
00609576010132BD AffirmPuritan Medical ProductsKXG2026-07-08
00609576381539Puritan®Puritan Medical ProductsKXG2026-07-08
00609576381782Puritan®Puritan Medical ProductsKXG2026-07-08
00609576390302Puritan®Puritan Medical ProductsKXG2026-07-08
10609576380362Puritan®Puritan Medical ProductsKXG2026-07-08
10609576381413Puritan®Puritan Medical ProductsKXG2026-07-08
00884999051737RealTimeABBOTT MOLECULAR INC.KXG2026-07-06
00884999051744Alinity mABBOTT MOLECULAR INC.KXG2026-07-06
00609576010378BD ProbeTecPuritan Medical ProductsKXG2026-07-02
00609576390142PuritanPuritan Medical ProductsKXG2026-07-02
00609576360251Puritan® Dry Transport System Sterile Flocked Collection DevicePuritan Medical ProductsKXG2026-05-29
08809262391039Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391053Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391060Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391077Specimen Collection SwabHLB CO.,LTDKXG2025-10-28