BinaxNOW Streptococcus pneumoniae Antigen Card

FDA UDI

Class I (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name: BinaxNOW Streptococcus pneumoniae Antigen Card FDA UDI
Generic Name: Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name: The BinaxNOW Streptococcus pneumoniae Antigen Card is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid of patients with meningitis. FDA UDI
Model / Reference: 710-000 FDA UDI
Description: The BinaxNOW Streptococcus pneumoniae Antigen Card is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid of patients with meningitis. FDA UDI

Identifiers

Primary DI / UDI-DI: 10811877011061 FDA UDI
510(k) Number: K012521 FDA UDI
FDA Product Code: GTZ FDA UDI
GMDN Term: Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

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

Cleared under the same submission

K012521 also covers:

BinaxNOW Streptococcus pneumoniae Control Swab Pack — Alere Scarborough, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Alere Scarborough, Inc.

Sources (1)

FDA UDI 7c1e7b32-03a6-4d56-b3d4-6288b23dff48 34 fields · synced May 30, 2026