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Abiogenix FAST Spiral Nasopharyngeal Swab

FDA UDI

Class I (US FDA UDI)

by Abiogenix Inc

Identity

Trade Name
Abiogenix FAST Spiral Nasopharyngeal Swab FDA UDI
Generic Name
Oral/upper respiratory tract specimen collection swab FDA UDI
Device Name
FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Non-Sterile, Case/1000 FDA UDI
Model / Reference
NP-SWAB-080-1000-NS FDA UDI
Description
FAST Spiral Nasopharyngeal Swab, 80 mm Break Point, Packaged and Non-Sterile, Case/1000 FDA UDI

Identifiers

Catalog Number
NP-SWAB-080-1000-NS FDA UDI
Primary DI / UDI-DI
00860003936832 FDA UDI
FDA Product Code
KXF FDA UDI
GMDN Term
Oral/upper respiratory tract specimen collection swab FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Depth — 80 Millimeter FDA UDI

Category: Oral/upper respiratory tract specimen collection swab

Abiogenix FAST Spiral Nasopharyngeal Swab by Abiogenix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/upper respiratory tract specimen collection swab.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abiogenix Inc

Sources (1)

  • FDA UDI f6eed64a-871a-42de-a0c6-feef6d165880 35 fields · synced Jun 8, 2026