FDA.reportPublic FDA data

C. DIFFICILE TOXIN ANTITOXIN KIT

Primary DI
00857031002066
Brand
C. DIFFICILE TOXIN ANTITOXIN KIT
Company
TECHLAB, INC.
Model
T5000
Device description
The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. 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
2020-01-24
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
K923463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923463000CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KITTechlab, Inc.1993-02-01LLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002066008570310020668570310020660857031002066

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile antigen IVD, kit, cell culture assayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of the cytotoxicity of antigens to Clostridium difficile bacteria [e.g., toxin A and/or toxin B] in a clinical specimen, using a cell culture assay.

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
00857031002646C. DIFFICILE TOX A/B IIT5015XB2021-05-07
00857031002660C. DIFF CHEK - 60TL50252021-05-03
00857031002639H. PYLORI CHEK T5051B2021-03-12
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
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
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