FDA.reportPublic FDA data

VIDAS® C. difficile Toxin A & B

Primary DI
03573026229146
Brand
VIDAS® C. difficile Toxin A & B
Company
BIOMERIEUX SA
Model
30118-01
Device description
The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens
Published
2019-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K080931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080931000VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYbioMerieux, Inc.2008-06-11LLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026229146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026229146035730262291463573026229146

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
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
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

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
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