FDA.reportPublic FDA data

BinaxNOW Streptococcus pneumoniae Antigen Card

Primary DI
10811877011061
Brand
BinaxNOW Streptococcus pneumoniae Antigen Card
Company
Alere Scarborough, Inc.
Model
710-000
Device description
The BinaxNOW Streptococcus pneumoniae Antigen Card is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae antigen in the urineof patients with pneumonia and in the cerebral spinal fluid of patients with meningitis.
Published
2020-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GTZAntisera, All Groups, Streptococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTZAntisera, All Groups, Streptococcus Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012521000BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.2001-11-30GTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877011061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701106110811877011061

GMDN Terms#

Term, Definition table
TermDefinition
Streptococcus pneumoniae antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from Streptococcus pneumoniae bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811877010064ISOSTAT® Consumables50C92016-09-05
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self Test200023502026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self Test200023512026-05-06
10811877011245WOUNDCHEK™ Bacterial Status360006US2020-05-26
00811877012153ID NOW InstrumentNAT-024R2025-08-01
00811877011477BinaxNOW COVID-19 Antigen Self Test195-1402023-09-05
00811877011118BinaxNOW COVID-19 Antigen Self Test195-1702023-08-11
00811877011729BinaxNOW COVID-19 Antigen Self Test195-1802022-10-03
00811877011408BinaxNOW COVID-19 Antigen Self Test195-1602021-04-21
10811877010934Osteomark NTx Urine90062020-09-16
10811877010941Osteomark NTx Serum90212020-09-16
00811877010050ISOSTAT® Press and Rack50C22016-09-05
00811877010098ISOSTAT® Containment Adapter50C12016-09-03
00811877012030BinaxNOW COVID-19/Flu A&B Combo Self Test20002050 2025-01-30
00811877012047BinaxNOW COVID-19/Flu A&B Combo Self Test20002056 2025-01-30
00811877012054BinaxNOW COVID-19/Flu A&B Combo Self Test200020512025-01-30
00811877012061BinaxNOW COVID-19/Flu A&B Combo Self Test20002057 2025-01-30
00811877012078BinaxNOW COVID-19/Flu A&B Combo Self Test20002052 2025-01-30
00811877012085BinaxNOW COVID-19/Flu A&B Combo Self Test20002058 2025-01-30
00811877012092BinaxNOW COVID-19/Flu A&B 20002054 2025-01-30

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