FDA.reportPublic FDA data

Abiogenix FAST Spiral Nasopharyngeal Swab

Primary DI
00860003936832
Brand
Abiogenix FAST Spiral Nasopharyngeal Swab
Company
ABIOGENIX INC
Model
NP-SWAB-080-1000-NS
Catalog number
NP-SWAB-080-1000-NS
Device description
FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Non-Sterile, Case/1000
Published
2020-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003936832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003936832008600039368328600039368320860003936832

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal swabA sterile device designed as a piece of absorbent material, with no additives, on a stick and intended to be used for the collection, and preservation and/or transport, of a clinical specimen from the nasopharynx for culture, analysis, and/or other investigation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth80Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
801937041
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003936801Abiogenix FAST Spiral Nasopharyngeal SwabNP-SWAB-080-1-SNP-SWAB-080-NS-12020-05-29
00860003936818Abiogenix FAST Spiral Nasopharyngeal SwabNP-SWAB-080-1000-SNP-SWAB-080-1000-S2020-05-29
00860003936825Abiogenix FAST Spiral Nasopharyngeal SwabNP-SWAB-080-100-NSNP-SWAB-080-100-NS2020-05-29
00860003936849Abiogenix FAST Spiral Nasopharyngeal SwabNP-SWAB-080-100-SNP-SWAB-080-100-S2020-05-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817522013377SwabezeKENTEC MEDICAL, INC.KXF2024-06-28
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