FDA.reportPublic FDA data

Simplexa™ VZV Swab Direct

Primary DI
20816101025712
Brand
Simplexa™ VZV Swab Direct
Company
DIASORIN MOLECULAR LLC
Model
MOL3655
Catalog number
MOL3655
Published
2019-12-13
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
PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion SamplesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192376000Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC2019-11-26PGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101025712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102571220816101025712

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) 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 varicella-zoster virus (VZV) 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) 240-6500ts.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
00884999052062Alinity mABBOTT MOLECULAR INC.PGI2025-11-20
00884999050594Alinity mABBOTT MOLECULAR INC.PGI2024-07-27
00884999050570Alinity mABBOTT MOLECULAR INC.PGI2024-07-26
00884999050587Alinity mABBOTT MOLECULAR INC.PGI2024-07-26
30014613340119SavannaDIAGNOSTIC HYBRIDS, INC.PGI2024-04-30
00840733102158Alethia™ HSV 1&2 External Control KitMERIDIAN BIOSCIENCE, INC.PGI2019-01-09
00840733102219Alethia™ HSV 1&2MERIDIAN BIOSCIENCE, INC.PGI2019-01-09
03661540950025HSV 1&2 ELITe MGB AssayElitechgroup Mdx LLCPGI2018-12-14
30014613336105SolanaDIAGNOSTIC HYBRIDS, INC.PGI2018-08-07
00840733101151illumigene HSV 1&2 External Control KitMERIDIAN BIOSCIENCE, INC.PGI2016-09-23
00840733101182illumigene HSV 1&2MERIDIAN BIOSCIENCE, INC.PGI2016-09-23
30014613311027LyraQUIDEL CORPORATIONPGI2016-09-15
00840487100295ARIES® HSV 1&2 AssayLUMINEX CORPORATIONPGI2016-09-09