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COVID-19 Swab Transport Accessory Pack

FDA UDI

Class I (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
COVID-19 Swab Transport Accessory Pack FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
Swab Transport Tubes intended for use only with ID NOW and BinaxNOW COVID-19 assays manufactured by Abbott Diagnostics Scarborough, Inc. FDA UDI
Model / Reference
190-010 FDA UDI
Description
Swab Transport Tubes intended for use only with ID NOW and BinaxNOW COVID-19 assays manufactured by Abbott Diagnostics Scarborough, Inc. FDA UDI

Identifiers

Primary DI / UDI-DI
10811877011313 FDA UDI
FDA Product Code
LXG FDA UDI
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General specimen container IVD, no additive/medium

COVID-19 Swab Transport Accessory Pack by Alere Scarborough, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI 13b3df57-d842-4b3e-a013-a10bac3de54a 33 fields · synced Jun 6, 2026