FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516744065
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
B1029-440
Catalog number
B1029-440
Device description
Bartels ELISA Legionella Urinary Antigen
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K991074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991074000BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTIntracel Corp.1999-12-21MJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516744065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516744065053915167440655391516744065

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-325-3424Customerservice@trinityusa.com

Regulatory Flags#

DUNS number
623214079
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
05391516746595Immco Diagnostics517551752019-10-25
05391516743914Trinity Biotech233900023390002016-09-19
05391516742276Trinity Biotech805A805A2017-05-07
05391516743938Trinity Biotech233910023391002016-09-23
05391516746533Trinity Biotech5257002019-12-27
05391516747455Trinity Biotech43842402019-12-31
05391516743822Trinity Biotech233817023381702016-09-22
05391516743860Trinity Biotech233857023385702016-09-22
05391516747172Trinity Biotech233857123385712016-09-22
05391516747202Trinity Biotech234698023469802016-09-19
05391516747387BartelsB1029-90CB1029-90C2017-05-07
05391516747394BartelsB1029-90DB1029-90D2017-05-07
05391516743372Trinity Biotech232510023251002016-09-21
05391516746960Trinity Biotech232510123251012016-09-21
05391516746588Bio-StatYY601262019-12-30
05391516747424Phoenix BiotechTS-96-Bulk2019-12-30
05391516747493Immco230AWI2019-12-30
05391516746519Trinity Biotech8271022019-12-27
05391516746526Trinity Biotech9154012019-12-27
05391516746687Bio-Rad72517725172019-12-27

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
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