← Back to catalogue

Alere i Strep A 2

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
Alere i Strep A 2 FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens. FDA UDI
Model / Reference
734-000 FDA UDI
Description
A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens. FDA UDI

Identifiers

Primary DI / UDI-DI
10811877010040 FDA UDI
510(k) Number
K173653 FDA UDI
FDA Product Code
PGX FDA UDI
OOI FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) 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

Yes

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 2 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alere Scarborough, Inc.

Sources (1)

  • FDA UDI d944c075-dad9-4177-9e77-b703f41644a1 35 fields · synced May 30, 2026