FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516747950
Brand
Trinity Biotech
Company
MARDX DIAGNOSTICS, INC.
Model
B1029-70
Catalog number
B1029-70
Device description
Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests
Published
2016-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCBAntigen, C. Difficile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCBAntigen, C. DifficileMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833447000CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-Bartels Immunodiagnostic Supplies, Inc.1984-05-21MCB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516747950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747950053915167479505391516747950

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile 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 Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-325-3424info@trinitybiotech.com

Regulatory Flags#

DUNS number
154281349
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
05391516747585Trinity Biotech90-160790-16072016-09-18
05391516747943Trinity Biotech90-161090-16102016-09-19
05391516748698Trinity Biotech20-0464820-046482016-09-18
05391516748919Trinity Biotech20-0400620-040062016-09-18
05391516748926Trinity Biotech20-0400220-040022016-09-18
05391516747851Trinity Biotech40-3025G40-3025G2016-09-18
05391516746182Trinity Biotech32-5100G32-5100G2016-09-18
05391516746199Trinity Biotech32-5100M32-5100M2016-09-18
05391516747721Trinity Biotech40-101340-10132016-09-19
05391516747738Trinity Biotech41-900241-90022016-09-19
05391516748735Trinity Biotech44-2020GV44-2020GV2016-09-18
05391516748742Trinity Biotech44-2020M44-2020M2016-09-19
05391516746151Trinity Biotech30-712030-71202016-09-18
05391516746168Trinity Biotech30-718030-71802016-09-18
05391516746175Trinity Biotech30-736030-73602016-09-18
05391516746205Trinity Biotech40-2075G40-2075G2016-09-18
05391516746212Trinity Biotech40-2075M40-2075M2016-09-18
05391516746229Trinity Biotech40-5065G40-5065G2016-09-18
05391516746236Trinity Biotech40-5065G/B40-5065G/B2016-09-18
05391516746243Trinity Biotech40-5065M40-5065M2016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033891322748CHORUS CLIA CLOSTRIDIUM DIFFICILE GDHDIESSE DIAGNOSTICA SENESE SPAMCB2025-08-19
00840733101687PREMIER C. difficile GDHMERIDIAN BIOSCIENCE, INC.MCB2020-09-21
00840733101793ImmunoCard C. difficile GDHMERIDIAN BIOSCIENCE, INC.MCB2020-08-11
03573026444204VIDAS® C. difficile GDHBIOMERIEUX SAMCB2019-11-19
00857031002141C. DIFF QUIK CHEKTECHLAB, INC.MCB2018-09-28
05391516747936Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-19
05391516747998Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-19
05391516748841Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-19
05391516748858Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-19
05391516748797Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-18
05391516748803Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-18