FDA.reportPublic FDA data

VIDAS® C. difficile GDH

Primary DI
03573026444204
Brand
VIDAS® C. difficile GDH
Company
BIOMERIEUX SA
Model
30125-01
Device description
VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen
Published
2019-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K132010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132010000VIDAS C DIFFICILE GDHBiomerieux S.A.2013-10-09MCB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026444204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026444204035730264442043573026444204

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile antigen IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen.

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
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
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
05391516747950Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-18
05391516748797Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-18
05391516748803Trinity BiotechMARDX DIAGNOSTICS, INC.MCB2016-09-18