FDA.reportPublic FDA data

TRU Legionella

Primary DI
00840733101267
Brand
TRU Legionella
Company
MERIDIAN BIOSCIENCE, INC.
Model
751930
Catalog number
751930
Device description
The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K113190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113190000TRU LEGIONELLAMeridian Bioscience, Inc.2012-02-24MJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101267008407331012678407331012670840733101267

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

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
05391516744065Trinity BiotechCLARK LABORATORIES, INC.MJH2016-09-23
05391516747202Trinity BiotechCLARK LABORATORIES, INC.MJH2016-09-19
10811877010460Binax® Legionella Urinary Antigen EIAAlere Scarborough, Inc.MJH2016-09-03
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