FDA.reportPublic FDA data

Simplexa™ C. difficile Universal Direct

Primary DI
20816101025583
Brand
Simplexa™ C. difficile Universal Direct
Company
DIASORIN MOLECULAR LLC
Model
MOL2975
Catalog number
MOL2975
Published
2016-09-22
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
OMNC. Difficile Nucleic Acid Amplification Test Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMNC. Difficile Nucleic Acid Amplification Test AssayMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113433000SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTFocus Diagnostics, Inc.2012-04-04OMN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101025583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102558320816101025583

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
562-240-6500DxTs@focusdx.com
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
20816101029062LIAISON NES® Group A StrepNES2850NES28502026-07-23
20816101029079LIAISON NES® Group A Strep Control Swab KitNES2860NES28602026-07-23
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitNES4460NES44602026-01-22
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733102134Alethia™ C. difficile External Control KitMERIDIAN BIOSCIENCE, INC.OMN2019-01-09
00840733102172Alethia™ C. difficileMERIDIAN BIOSCIENCE, INC.OMN2019-01-09
07332940000028Xpert C. difficile/EpiCEPHEIDOMN2018-01-29
07332940000042Xpert C. difficile/EpiCEPHEIDOMN2018-01-29
00840733101120illumigene C. difficile External Control KitMERIDIAN BIOSCIENCE, INC.OMN2016-09-23
00840733101168illumigene C. difficileMERIDIAN BIOSCIENCE, INC.OMN2016-09-23
B178GBCDIFF100Portrait Toxigenic C. difficile AssayGREAT BASIN SCIENTIFIC, INC.OMN2016-09-23