FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516747547
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
40-1013
Catalog number
40-1013
Device description
B. burgdorferi Wash Buffer (10x)
Published
2019-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSRReagent, Borrelia Serological Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSRReagent, Borrelia Serological ReagentMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K892206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K892206000MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEMMardx Diagnostics, Inc.1989-08-15LSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516747547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747547053915167475475391516747547

GMDN Terms#

Term, Definition table
TermDefinition
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody 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 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
623214079
Device count
1
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
00845533002950Anti-Borrelia VlsE1/pepC10 IgG/IgMZEUS SCIENTIFIC, INC.LSR2026-02-18
00850049545259AccuDiag ™Diagnostic Automation, Inc.LSR2024-03-06
00850054026378QMedix™Diagnostic Automation, Inc.LSR2024-01-31
04048474028096B. burgdorferi IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028102Borrelia burgdorferi IgG (Lyme) ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028119Borrelia burgdorferi IgM (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
00840239028099B. burgdorferi IgG/IgM ELISADRG International IncLSR2023-08-24
00840239028105Borrelia burgdorferi IgG (Lyme) ELISADRG International IncLSR2023-08-24
00840239028112Borrelia burgdorferi IgM (Lyme) ELISA DRG International IncLSR2023-08-24
EVIRBTCFDK1Borrelia All-In-One ViraChip Deca KitViramed Biotech AGLSR2022-11-08
EVIRBTCFOK1Borrelia All-In-One ViraChip Test KitViramed Biotech AGLSR2022-11-08
B350GSD0110310Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-10-28
B350GSD0110250Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
B350GSD0110260Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
00845533001854ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test SystemZEUS SCIENTIFIC, INC.LSR2022-04-27
00894175000022AccuDiag ™ Diagnostic Automation, Inc.LSR2021-08-10
B350GSD0110270Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test KitGold Standard Diagnostics CorporationLSR2021-07-20
B350GSD0110220Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test KitGold Standard Diagnostics CorporationLSR2020-07-01
B350GSD0110230Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test KitGold Standard Diagnostics CorporationLSR2020-07-01
05391516746779Trinity BiotechCLARK LABORATORIES, INC.LSR2019-12-26
05391516746816Trinity BiotechCLARK LABORATORIES, INC.LSR2019-12-26
30014613337799SofiaQUIDEL CORPORATIONLSR2019-12-10
05391516747486Trinity BiotechCLARK LABORATORIES, INC.LSR2019-11-05
05391516746625MarDxCLARK LABORATORIES, INC.LSR2019-10-25
05391516747134Trinity BiotechCLARK LABORATORIES, INC.LSR2019-08-06
03610520506394BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-05-13
03610520506455BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-04-30
03610520506462BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-04-30
30014613202981SofiaQUIDEL CORPORATIONLSR2018-08-07
B350GSD0110240Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2018-05-21