FDA.reportPublic FDA data

BD MAX™ Cdiff (US)

Primary DI
00382904434182
Brand
BD MAX™ Cdiff (US)
Company
BECTON, DICKINSON AND COMPANY
Model
443418
Catalog number
443418
Device description
BD MAX™ Cdiff (US)
Published
2016-05-19
Public version status
Update
Distribution status
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
K130470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130470000BD MAX CDIFF ASSAY, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc. (Bd Diagnostics)2013-04-02OZN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904434182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904434182003829044341823829044341820382904434182

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)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
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
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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
00628055344124Revogene® C. difficileMeridian Bioscience Canada IncOZN2019-10-21
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