FDA.reportPublic FDA data

Abiogenix FAST Spiral Nasopharyngeal Swab

Primary DI
00860003936801
Brand
Abiogenix FAST Spiral Nasopharyngeal Swab
Company
ABIOGENIX INC
Model
NP-SWAB-080-1-S
Catalog number
NP-SWAB-080-NS-1
Device description
FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Sterilized, Single
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00860003936801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003936801008600039368018600039368010860003936801

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

Regulatory Flags#

DUNS number
801937041
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00860003936832Abiogenix FAST Spiral Nasopharyngeal SwabNP-SWAB-080-1000-NSNP-SWAB-080-1000-NS2020-05-29
00860003936849Abiogenix FAST Spiral Nasopharyngeal SwabNP-SWAB-080-100-SNP-SWAB-080-100-S2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
58053326007021FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
10197344169214CARINGMEDLINE INDUSTRIES, INC.KXG2025-12-05
00840456216675JMUJMU DENTAL, INCKXG2025-11-12
00840456216682JMUJMU DENTAL, INCKXG2025-11-12
M220767003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768013Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
00840456214916JMUJMU DENTAL, INCKXG2025-07-15
00840456214923JMUJMU DENTAL, INCKXG2025-07-15
58053326011653CLASSIQSwabCOPAN ITALIA SPAKXG2025-07-03
58053326011660CLASSIQSwabs™ FLOQ Swabs® COPAN ITALIA SPAKXG2025-07-03
00842558116402BactiSwab Dry PK/100REMEL, INC.KXG2025-06-19
00810180840958LabChoice Transport Swabs, Wooden Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00810180840965LabChoice Transport Swabs, Wooden Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00810180840972LabChoice Transport Swabs, Snappable Polystyrene Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00840117329706LabChoice Transport Swabs, Snappable Polystyrene Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00840165400372Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
00840165400396Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
05060166524524Oracol MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166525743Oracol SwabMALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166524531Oracol+MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
58053326011684FLOQSwabs® COPAN ITALIA SPAKXG2024-12-18
00603266511848Super BrushSuper Brush, LLCKXG2024-08-30
10603266530839Super BrushSuper Brush, LLCKXG2024-08-30
10603266531874Super BrushSuper Brush, LLCKXG2024-08-30
10603266533830Super BrushSuper Brush, LLCKXG2024-08-30
10603266534875Super BrushSuper Brush, LLCKXG2024-08-30
10603266541835Super BrushSuper Brush, LLCKXG2024-08-30
00842558116501BactiSwab (Dry) CS/500Remel Inc.KXG2024-08-14
58053326011509FLOQSwabs® COPAN ITALIA SPAKXG2024-07-02