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Alere™ i Strep A Control Swab Kit

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
Alere™ i Strep A Control Swab Kit FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus nucleic acid IVD, control FDA UDI
Device Name
Control Swabs intended for use only with the Alere i Strep A product. FDA UDI
Model / Reference
733-080 FDA UDI
Description
Control Swabs intended for use only with the Alere i Strep A product. FDA UDI

Identifiers

Primary DI / UDI-DI
10811877010866 FDA UDI
FDA Product Code
PGX FDA UDI
OOI FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.2680 FDA UDI
862.2570 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Alere™ i Strep A Control Swab Kit by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 0bd9345b-ba34-4fd8-b4ae-6826409a8a3c 34 fields · synced May 30, 2026