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SNT Biotech

FDA UDI

Class I (US FDA UDI)

by Shenzhen Dakewe Bio-engineering Co., Ltd

Identity

Trade Name
SNT Biotech FDA UDI
Generic Name
Oral/upper respiratory tract specimen collection swab FDA UDI
Device Name
Oropharyngeal swab. FDA UDI
Model / Reference
OP FDA UDI
Description
Oropharyngeal swab. FDA UDI

Identifiers

Primary DI / UDI-DI
16973471969866 FDA UDI
FDA Product Code
KXG 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oral/upper respiratory tract specimen collection swab

This oral/upper respiratory tract specimen collection swab is a single-use device designed for the safe and accurate collection, preservation, and transport of saliva or other specimens from various parts of the upper respiratory system. By using this swab, healthcare professionals can obtain high-quality samples for culture, analysis, and investigation.

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
Shenzhen Dakewe Bio-engineering Co., Ltd

Sources (1)

  • FDA UDI 136f466d-c2b2-48d1-a57f-1029b29ae03b 33 fields · synced Jun 23, 2026