FDA.reportPublic FDA data

Simplexa™ HSV 1 & 2 Direct

Primary DI
20816101025507
Brand
Simplexa™ HSV 1 & 2 Direct
Company
DIASORIN MOLECULAR LLC
Model
MOL2150
Catalog number
MOL2150
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
OQOHerpes Simplex Virus Nucleic Acid Amplification Assay
PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQOHerpes Simplex Virus Nucleic Acid Amplification AssayMicrobiology2
PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based PanelMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN130049000
K150962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN130049000SIMPLEXA HSV 1&2 DIRECTFocus Diagnostics2014-03-21PGH
K150962000Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics2015-08-28OQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101025507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102550720816101025507

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 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 herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a nucleic acid technique (NAT).

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
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
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
10816101025029Integrated Cycler (220V)MOL1011MOL10112016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08885013953664Sentosa SA201 HSV-1/2 PCR TestVELA OPERATIONS SINGAPORE PTE. LTD.OQO2018-04-16
25420045510187Aptima®Hologic, Inc.OQO2018-01-16
15420045507210Aptima®Hologic, Inc.OQO2017-06-23
15420045507227Aptima®Hologic, Inc.OQO2017-06-23
15420045507234Aptima®Hologic, Inc.OQO2017-06-23
25420045507248Aptima®Hologic, Inc.OQO2017-02-16
04053228004660artus® HSV-1/2 QS-RGQ MDx KitQIAGEN GmbHOQO2017-01-04
00875197004434cobas® 4800 System Lysis KitRoche Molecular Systems, Inc.OQO2016-09-24
00875197004458cobas® 4800 Systems Internal Control KitRoche Molecular Systems, Inc.OQO2016-09-24
00875197005264cobas® 4800 System Lysis KitRoche Molecular Systems, Inc.OQO2016-09-24
20816101025514Simplexa™ HSV 1 & 2 Positive Control PackDIASORIN MOLECULAR LLCOQO2016-09-22
20816101025514Simplexa™ HSV 1 & 2 Positive Control PackDIASORIN MOLECULAR LLCPGH2016-09-22
30014613312109AmpliVueQUIDEL CORPORATIONOQO2016-09-15
00840487101032Mutlicode®-RTx HSV 1&2 KitLUMINEX CORPORATIONOQO2016-09-09
00382904417482Control Set for the BD ProbeTec™ Herpes Simplex VirusesBECTON, DICKINSON AND COMPANYOQO2016-07-07
00382904417499BD ProbeTec™ Herpes Simplex Viruses Assays Reagent PackBECTON, DICKINSON AND COMPANYOQO2016-07-07