FDA.reportPublic FDA data

Clostridium difficile (CDF) Extraction Tray

Primary DI
00857573006256
Brand
Clostridium difficile (CDF) Extraction Tray
Company
NANOSPHERE, INC.
Model
20-009-022
Device description
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
Published
2016-09-23
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
K123197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123197000VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)Nanosphere, Inc.2012-12-05OZN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101650PrimaryGS10
00857573006256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101650008404871016508404871016500840487101650
00857573006256008575730062568575730062560857573006256

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal pathogen nucleic acid IVD, kit, microarrayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types microorganisms associated with gastrointestinal disease, in a clinical specimen, using a microarray method. Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-837-4436productsupport@nanosphere.us
+1(877)785-2323support@luminexcorp.com

Regulatory Flags#

DUNS number
164757242
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857573006027Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-0012016-09-23
00857573006348Hypercoagulation Panel (HC) Sample Buffer30-001-0012016-09-23
00857573006133Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge20-006-0202016-09-23
00857573006164Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge20-006-0242016-09-23
00857573006232Respiratory Virus Plus (RV+) Extraction Tray20-009-0202016-09-23
00857573006263Respiratory Pathogens Flex (RP Flex) Extraction Tray20-009-0242016-09-23
00857573006294Respiratory Virus Plus (RV+) Amplification Tray20-011-0202016-09-23
00857573006324Respiratory Pathogens Flex (RP Flex) Amplification Tray20-011-0242016-09-23
00857573006119Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge20-006-0182016-09-23
00857573006218Gram-Positive Blood Culture (BC-GP) Extraction Tray20-009-0182016-09-23
00857573006287Gram-Positive Blood Culture (BC-GP) Utility Tray20-011-0182016-09-23
00857573006003 Verigene® Reader 10-0000-022016-09-23
00857573006010 Verigene® Processor SP 10-0000-072016-09-23
00857573006386 Verigene® Processor 10-0000-042016-09-23
00857573006393 Verigene® Reader (Refurbished)10-0000-02R2016-11-04
00857573006409 Verigene® Processor SP (Refurbished)10-0000-07R2016-11-04
00857573006041Enteric Pathogens (EP) Nucleic Acid Test Cartridge20-006-0232016-09-23
00857573006058Enteric Pathogens (EP) Extraction Tray20-009-0232016-09-23
00857573006065Enteric Pathogens (EP) Stool Sample Preparation Kit30-002-0232016-09-23
00857573006089Enteric Pathogens (EP) Amplification Tray20-011-0232016-09-23

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
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