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BinaxNOW Streptococcus pneumoniae Control Swab Pack

FDA UDI

Class I (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name
BinaxNOW Streptococcus pneumoniae Control Swab Pack FDA UDI
Generic Name
Streptococcus pneumoniae antigen IVD, control FDA UDI
Device Name
Control swabs intended for use only with S. pneumoniae product FDA UDI
Model / Reference
710-010 FDA UDI
Description
Control swabs intended for use only with S. pneumoniae product FDA UDI

Identifiers

Primary DI / UDI-DI
10811877011092 FDA UDI
510(k) Number
K012521 FDA UDI
FDA Product Code
GTZ FDA UDI
GMDN Term
Streptococcus pneumoniae antigen IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3740 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: Streptococcus pneumoniae antigen IVD, control

BinaxNOW Streptococcus pneumoniae Control Swab Pack by Alere Scarborough, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K012521 also covers:

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 289b1d67-ccc8-46a2-9315-7a85bd1f6ff0 34 fields · synced Jun 1, 2026