FDA.reportPublic FDA data

Simplexa COVID-19 Positive Control Pack

Primary DI
20816101027037
Brand
Simplexa COVID-19 Positive Control Pack
Company
DIASORIN MOLECULAR LLC
Model
MOL4160
Catalog number
MOL4160
Published
2023-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101027037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102703720816101027037

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 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 from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

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
5622406500TS.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
20816101027136Simplexa COVID-19 Positive Control GEN II Pack DIASORIN MOLECULAR LLCQQX2025-09-17
15420045516991Aptima®Hologic, Inc.QQX2025-03-14
15420045517004Aptima®Hologic, Inc.QQX2025-03-14
15420045517035Aptima®Hologic, Inc.QQX2025-03-14
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019422Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay KitLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
80190302019438Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
10190302019446Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR ControlLIFE TECHNOLOGIES CORPORATIONQQX2025-02-17
07332940008581GeneXpert®CEPHEIDQQX2024-01-22
00382904453619BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-12-09
00382904453732BD Respiratory Viral Panel for BD MAX™ SystemBECTON, DICKINSON AND COMPANYQQX2023-09-28
00875197006841cobas® SARS-CoV-2 Qualitative 192TRoche Molecular Systems, Inc.QQX2023-09-12
00875197006858cobas® SARS-CoV-2 Qualitative Control KitRoche Molecular Systems, Inc.QQX2023-09-12
00875197006933cobas® SARS-CoV-2 Qualitative 480TRoche Molecular Systems, Inc.QQX2023-09-12
20816101027020Simplexa COVID-19 DirectDIASORIN MOLECULAR LLCQQX2023-06-16
00851458005228BioFire® COVID-19 Test 2BIOFIRE DEFENSE, LLCQQX2023-02-16
00851458005235BioFire® COVID-19 Test 2BIOFIRE DEFENSE, LLCQQX2023-02-16
06973342000530COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-02-02
06973342000158COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., Ltd.QQX2023-01-30
10789594001002MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001088MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001095MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001101MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001354MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001361MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16
10789594001378MicrobrushYOUNG MICROBRUSH, LLCQQX2022-08-16