FDA.reportPublic FDA data

Revogene® C. difficile

Primary DI
00628055344124
Brand
Revogene® C. difficile
Company
Meridian Bioscience Canada Inc
Model
410300
Catalog number
410300
Device description
The Revogene® C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The Revogene C. difficile assay is intended to aid in the diagnosis of CDI.
Published
2019-10-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZNC. Difficile Toxin Gene Amplification Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZNC. Difficile Toxin Gene Amplification AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172569000GenePOC CDiffGenepoc, Inc.2017-11-22OZN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055344124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055344124006280553441246280553441240628055344124

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-343-3858MBI-TechService@meridianbioscience.com

Regulatory Flags#

DUNS number
204006360
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
00628055344100Revogene®6102106102102019-11-01
00628055344117Revogene® GBS LB4102004102002019-10-21
00628055344131MOCK PIE6102086102082019-10-21
00628055344162Revogene® Carba C4105004105002019-10-21
00628055344179Revogene® Strep A4104004104002019-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G491CDF20Toxigenic C. difficile Direct TestVela Operations USA Inc.OZN2024-01-18
G491CDF21Toxigenic C. difficile Direct TestVela Operations USA Inc.OZN2024-01-18
G491CDF2SPD0Toxigenic C. difficile Direct Test - Sample PrepVela Operations USA Inc.OZN2024-01-18
00840733102349Revogene C. difficileMERIDIAN BIOSCIENCE, INC.OZN2020-07-15
00840487101605Clostridium difficile (CDF) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOZN2019-12-05
00840487101650Clostridium difficile (CDF) Extraction TrayLUMINEX CORPORATIONOZN2019-12-05
00840487101704Clostridium difficile (CDF) Amplification TrayLUMINEX CORPORATIONOZN2019-12-05
00840487101735Clostridium difficile (CDF) Stool Sample Preparation KitLUMINEX CORPORATIONOZN2019-12-05
30014613336150SolanaDIAGNOSTIC HYBRIDS, INC.OZN2018-07-20
00628055344025GenePOC™ CDiff GenePoc IncOZN2017-12-29
00840487100059ARIES® C. difficile AssayLUMINEX CORPORATIONOZN2017-07-25
20816101025590Simplexa™ C. difficile DirectDIASORIN MOLECULAR LLCOZN2017-02-16
20816101025606Simplexa™ C. difficile Positive Control PackDIASORIN MOLECULAR LLCOZN2017-02-16
20816101025613Simplexa™ C.difficile Sample Prep KitDIASORIN MOLECULAR LLCOZN2017-02-16
04053228004646artus® C. difficile QS-RGQ MDx KitQIAGEN GmbHOZN2017-01-04
B178GBCDIFF100Portrait Toxigenic C. difficile AssayGREAT BASIN SCIENTIFIC, INC.OZN2016-09-23
00857573006157Clostridium difficile (CDF) Nucleic Acid Test CartridgeNANOSPHERE, INC.OZN2016-09-23
00857573006256Clostridium difficile (CDF) Extraction TrayNANOSPHERE, INC.OZN2016-09-23
00857573006317Clostridium difficile (CDF) Amplification TrayNANOSPHERE, INC.OZN2016-09-23
00857573006362Clostridium difficile (CDF) Stool Sample Preparation KitNANOSPHERE, INC.OZN2016-09-23
30014613311058LyraQUIDEL CORPORATIONOZN2016-09-15
30014613312017AmpliVueQUIDEL CORPORATIONOZN2016-09-15
00382904419165BD MAX™ SystemBECTON, DICKINSON AND COMPANYOZN2016-05-19
00382904434182BD MAX™ Cdiff (US)BECTON, DICKINSON AND COMPANYOZN2016-05-19