FDA.reportPublic FDA data

C. DIFFICILE TOX A/B II

Primary DI
00857031002646
Brand
C. DIFFICILE TOX A/B II
Company
TECHLAB, INC.
Model
T5015XB
Device description
The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
Published
2021-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LLHReagents, Clostridium Difficile Toxin

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003306000C. DIFFICILE TOX A/B IITechlab, Inc.2000-11-22LLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002646008570310026468570310026460857031002646

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614218634
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
00857031002547TRI-COMBO PARASITE SCREENT50322019-05-31
00857031002554C. DIFF QUIK CHEK COMPLETET50382019-05-31
00857031002073C. DIFFICILE TOX-B TEST30399U2020-01-24
00857031002530LEUKO EZ VUET50192020-01-24
00857031002561QuickVue TLI H. pylori Test203432019-05-30
00857031002226C. DIFF CHEK - 60T50252019-04-12
00857031002455CAMPYLOBACTER QUIK CHEKT50472019-04-12
00857031002301CRYPTOSPORIDIUM IIPT50142016-08-23
00857031002523H. PYLORI CHEK309962018-09-28
00857031002356LACTOFERRIN EZ VUET50182019-05-31
00857031002585QuickVue TLI Lactoferrin Test203452019-05-30
00857031002189LACTOFERRIN EZ VUE303532019-05-29
00857031002172LEUKO EZ VUET303552019-04-12
00857031002660C. DIFF CHEK - 60TL50252021-05-03
00857031002639H. PYLORI CHEK T5051B2021-03-12
00857031002066C. DIFFICILE TOXIN ANTITOXIN KITT50002020-01-24
00857031002264C. DIFFICILE TOX-B TESTT50032020-01-24
00857031002622QuickVue TLI H. pylori Stool Antigen Test203432019-09-26
00857031002196SHIGA TOXIN QUIK CHEKT306252019-08-06
00857031002417SHIGA TOXIN CHEKT306962019-08-06

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
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
00857031002370C. DIFF QUIK CHEK COMPLETETECHLAB, INC.LLH2018-08-07