FDA.reportPublic FDA data

Binax® Legionella Urinary Antigen EIA

Primary DI
10811877010460
Brand
Binax® Legionella Urinary Antigen EIA
Company
Alere Scarborough, Inc.
Model
851-000
Device description
For the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine.
Published
2016-09-03
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
MJHLegionella, Spp., Elisa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJHLegionella, Spp., ElisaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934965000BINAX LEGIONELLA URINARY ANTIGEN EIABinax, Inc.1994-09-20MJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701046010811877010460

GMDN Terms#

Term, Definition table
TermDefinition
Legionella pneumophila antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840239056450Legionella pneumophila IgG ELISADRG International IncMJH2023-08-25
05032384013227LEGIONELLA SPECIES TEST KITOXOID LIMITEDMJH2022-12-08
05713106105573ImmuView S. pneumoniae and L. pneumophila urinary antigen testSsi Diagnostica A/SMJH2022-10-25
05713106024515ImmuView S. pneumoniae and L. pneumophila urinary antigen testSsi Diagnostica A/SMJH2020-03-24
05391516746670BartelsCLARK LABORATORIES, INC.MJH2019-11-06
10811877011054BinaxNOW™ Legionella Control Swab PackAlere Scarborough, Inc.MJH2019-07-15
10811877011023BinaxNOW Legionella Urinary Antigen CardAlere Scarborough, Inc.MJH2019-07-08
04048474056457Legionella pneumophila IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMJH2019-06-10
00404847456455Legionella pneumophila IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMJH2019-06-10
04049016027508Anti-Legionella pneumophila ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGMJH2016-09-24
04049016027515Anti-Legionella pneumophila ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMJH2016-09-24
04049016027522Anti-Legionella pneumophila ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGMJH2016-09-24
05032384013197NAOXOID LIMITEDMJH2016-09-24
05032384013203NAOXOID LIMITEDMJH2016-09-24
05032384013210NAOXOID LIMITEDMJH2016-09-24
05032384060535NAOXOID LIMITEDMJH2016-09-24
05032384060542NAOXOID LIMITEDMJH2016-09-24
05032384061365NAOXOID LIMITEDMJH2016-09-24
00840733101267TRU LegionellaMERIDIAN BIOSCIENCE, INC.MJH2016-09-23
05391516744065Trinity BiotechCLARK LABORATORIES, INC.MJH2016-09-23
05391516747202Trinity BiotechCLARK LABORATORIES, INC.MJH2016-09-19
10811877010767Binax® Legionella EIA Wash Buffer Accessory KitAlere Scarborough, Inc.MJH2016-09-03
10811877010491Alere™ BinaxNOW® Legionella Control Swab KitAlere Scarborough, Inc.MJH2016-09-01
10811877010477Alere™ BinaxNOW® Legionella Urinary Antigen CardAlere Scarborough, Inc.MJH2016-09-01