FDA.reportPublic FDA data

Simplexa COVID-19 & Flu A/B Positive Control Pack

Primary DI
20816101027150
Brand
Simplexa COVID-19 & Flu A/B Positive Control Pack
Company
DIASORIN MOLECULAR LLC
Model
MOL4260
Catalog number
MOL4260
Published
2023-06-16
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
OOIReal Time Nucleic Acid Amplification System
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220963000Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC2023-03-17QOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101027150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102715020816101027150

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple viruses associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

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
562-2406500TS.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
00819704020074FINDER InstrumentBaebies, Inc.QOF2026-05-01
00819704020425FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.QOF2026-05-01
00819704020463FINDER Cleaning AccessoryBaebies, Inc.QOF2026-05-01
00819704020487FINDER RVP BufferBaebies, Inc.QOF2026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control SwabBaebies, Inc.QOF2026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control SwabBaebies, Inc.QOF2026-05-01
00850028489017MyrnaInflammatix, Inc.OOI2026-04-30
00850028489024TriVerityInflammatix, Inc.OOI2026-04-30
05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
05061098480032NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
00875197005240cobas® Cdiff TestRoche Molecular Systems, Inc.OOI2026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor KitRoche Molecular Systems, Inc.OOI2026-02-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007541cobas® Respiratory 4-flexRoche Molecular Systems, Inc.QOF2026-02-24
00875197005677cobas® CdiffRoche Molecular Systems, Inc.OOI2026-02-23
00875197005684cobas® Cdiff Control KitRoche Molecular Systems, Inc.OOI2026-02-23
10816101025142LIAISON NES® InstrumentDIASORIN MOLECULAR LLCOOI2026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCQOF2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCOOI2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCQOF2026-01-22
07332940009694GeneXpert®CEPHEIDOOI2026-01-19
07332940009700GeneXpert® XpressCEPHEIDOOI2026-01-19
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCQOF2026-01-14
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCOOI2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCOOI2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09