FDA.reportPublic FDA data

Simplexa™ C. difficile Positive Control Pack

Primary DI
20816101025606
Brand
Simplexa™ C. difficile Positive Control Pack
Company
DIASORIN MOLECULAR LLC
Model
MOL2960
Catalog number
MOL2960
Published
2017-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K163085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163085000Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC2017-02-14OZN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101025606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102560620816101025606

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 Temperature-30 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 838-4548technicalinfo.molecular@diasor
562-240-6500TS.Molecular@DiaSorin.com

Regulatory Flags#

DUNS number
080271715
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
20816101020243Rickettsia IFA IgGIF0100GIF0100G2026-03-13
20816101020250Rickettsia IFA IgMIF0100MIF0100M2026-03-13
20816101020342Q Fever IFA IgGIF0200GIF0200G2026-03-13
20816101020359Q Fever IFA IgMIF0200MIF0200M2026-03-13
20816101020397Arbovirus IFA IgGIF0300GIF0300G2026-03-13
20816101020403Arbovirus IFA IgMIF0300MIF0300M2026-03-13
20816101025538Simplexa™ Flu A/B & RSVMOL2600MOL26002016-09-22
20816101025507Simplexa™ HSV 1 & 2 DirectMOL2150MOL21502016-09-22
20816101025514Simplexa™ HSV 1 & 2 Positive Control PackMOL2160MOL21602016-09-22
10816101025142LIAISON NES® InstrumentNES1001NES10012026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)NES1001RNES1001R2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19NES4450NES44502026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitNES4460NES44602026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectMOL4450MOL44502026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackMOL4460MOL44602026-01-14
10816101020772R. rickettsii Substrate SlideIF0102IF01022025-12-16
10816101027375Blastomyces Primer PairMOL9206MOL92062025-12-16
20816101027136Simplexa COVID-19 Positive Control GEN II Pack MOL4165MOL41652025-09-17
10816101025005Integrated Cyler (110V)MOL1001MOL10012016-09-24
10816101025012Integrated Cyler (110V) Pre-OwnedMOL1001-PMOL1001-P2016-09-24

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
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