FDA.reportPublic FDA data

Simplexa™ Group A Strep Direct

Primary DI
20816101025569
Brand
Simplexa™ Group A Strep Direct
Company
DIASORIN MOLECULAR LLC
Model
MOL2850
Catalog number
MOL2850
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
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143651000Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackFocus Diagnostics, Inc.2015-03-18PGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816101025569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081610102556920816101025569

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus 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 Group A beta-haemolytic Streptococcus bacteria 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
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
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCPGX2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCPGX2024-05-03
00840733102325Revogene Strep AMERIDIAN BIOSCIENCE, INC.PGX2020-07-15
00628055344179Revogene® Strep AMeridian Bioscience Canada IncPGX2019-10-21
00628055344087GenePOC™ Strep AGenePoc IncPGX2019-04-30
10811877010552ID NOW Strep A 2Alere Scarborough, Inc.PGX2018-10-29
10811877010583ID NOW Strep A 2 Control Swab KitAlere Scarborough, Inc.PGX2018-10-29
30014613336136SolanaDIAGNOSTIC HYBRIDS, INC.PGX2018-07-23
07332940002503Xpert Xpress Strep ACEPHEIDPGX2018-06-29
10811877010040Alere i Strep A 2Alere Scarborough, Inc.PGX2018-06-28
10811877010200Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.PGX2018-06-28
07332940006372Xpert Xpress Strep ACEPHEIDPGX2018-01-29
07613336156544cobas Liat Strep A Script Version 1.27Roche Molecular Systems, Inc.PGX2017-11-17
00840487101469ARIES® Group A Strep AssayLUMINEX CORPORATIONPGX2017-11-07
07613336129692cobas® Liat® Strep A ScriptRoche Molecular Systems, Inc.PGX2016-09-24
00875197005622cobas® Strep A Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.PGX2016-09-24
00875197005646cobas® Strep A Quality Control Kit for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.PGX2016-09-24
20816101025576Simplexa™ Group A Strep Positive Control PackDIASORIN MOLECULAR LLCPGX2016-09-22
30014613311126LyraQUIDEL CORPORATIONPGX2016-09-15
30014613312123AmpliVueQUIDEL CORPORATIONPGX2016-09-15
30014613336082SolanaQUIDEL CORPORATIONPGX2016-09-15
10811877010859Alere™ i Strep AAlere Scarborough, Inc.PGX2016-09-03
10811877010866Alere™ i Strep A Control Swab KitAlere Scarborough, Inc.PGX2016-09-03