FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516748780
Brand
Trinity Biotech
Company
MARDX DIAGNOSTICS, INC.
Model
1206631
Catalog number
1206631
Device description
Uni-Gold™ C. difficile Toxin A/B Controls, 1 Positive and 1 Negative
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
LLHReagents, Clostridium Difficile Toxin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLHReagents, Clostridium Difficile ToxinMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516748780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516748780053915167487805391516748780

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile toxin A/B antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of toxin A and/or toxin B antigens from Clostridium difficile bacteria in a clinical specimen.

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
800-325-3424info@trinitybiotech.com

Regulatory Flags#

DUNS number
154281349
Device count
1
Premarket exempt
true
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
08033891322779CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINSDIESSE DIAGNOSTICA SENESE SPALLH2025-08-19
05032384519828ProSpecT™ Wash BufferOXOID LIMITEDLLH2024-07-05
05032384519903ProSpecT C. difficile Toxin A/B Microplate OXOID LIMITEDLLH2022-12-23
06974849369229Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.LLH2022-12-06
06974849369236Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.LLH2022-12-06
00848838027093Remel REMEL, INC.LLH2022-04-21
00848838068416Remel REMEL, INC.LLH2022-04-21
30848838027094Remel REMEL, INC.LLH2022-04-21
30848838068417Remel REMEL, INC.LLH2022-04-21
00857031002646C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2021-05-07
00857031002660C. DIFF CHEK - 60TECHLAB, INC.LLH2021-05-03
00840733101786ImmunoCard Toxins A & BMERIDIAN BIOSCIENCE, INC.LLH2020-09-21
00840733101694PREMIER Toxins A and BMERIDIAN BIOSCIENCE, INC.LLH2020-09-01
00857031002066C. DIFFICILE TOXIN ANTITOXIN KITTECHLAB, INC.LLH2020-01-24
00857031002073C. DIFFICILE TOX-B TESTTECHLAB, INC.LLH2020-01-24
00857031002264C. DIFFICILE TOX-B TESTTECHLAB, INC.LLH2020-01-24
03573026229146VIDAS® C. difficile Toxin A & BBIOMERIEUX SALLH2019-11-08
00857031002431C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2019-05-31
00857031002448C. DIFF CHEK - 60TECHLAB, INC.LLH2019-05-31
00857031002554C. DIFF QUIK CHEK COMPLETETECHLAB, INC.LLH2019-05-31
00857031002110C. DIFF CHEK - 60TECHLAB, INC.LLH2019-04-12
00857031002219C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2019-04-12
00857031002226C. DIFF CHEK - 60TECHLAB, INC.LLH2019-04-12
00857031002103C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2018-10-31
00857031002233C. DIFF CHEK - 60TECHLAB, INC.LLH2018-10-31
00857031002424C. DIFFICILE TOX A/B IITECHLAB, INC.LLH2018-09-28
00857031002042TOX A/B QUIK CHEKTECHLAB, INC.LLH2018-08-07
00857031002059C. DIFF QUIK CHEK COMPLETETECHLAB, INC.LLH2018-08-07
00857031002158C. DIFF QUIK CHEK COMPLETETECHLAB, INC.LLH2018-08-07
00857031002257TOX A/B QUIK CHEKTECHLAB, INC.LLH2018-08-07