FDA.reportPublic FDA data

Solana

Primary DI
30014613336136
Brand
Solana
Company
DIAGNOSTIC HYBRIDS, INC.
Model
M305
Catalog number
M305
Device description
Solana Strep A/C & G Assay
Published
2018-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K162274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162274000Solana Strep Complete AssayQuidel Corporation2016-10-25PGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613336136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333613630014613336136

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
117359612
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
30014613330288D3 Ultra01-010000.V201-010000.V22019-03-07
30014613330875D3 Fastpoint01-12350401-1235042019-03-07
00050428101735CVS Health At Home COVID-19 Test Kit204522895862025-08-08
30014613340089Savanna20382R20382R2024-07-19
30014613339304Savanna20382203822024-04-30
30014613340188CVS Health At Home COVID-19 Test Kit204522895862024-11-20
30014613330240D301-0005001-000502019-04-02
30014613311034LyraM103M1032016-09-15
30014613311157Quidel MolecularM115M1152018-11-16
30014613330752D3 FastpointRespiratory Virus ID Kit01-1200002016-09-15
30014613330769D3 Fastpoint01-120000.B101-120000.B12018-07-22
30014613330776D3 Fastpoint01-120000.B201-120000.B22018-07-22
30014613330813D3 FastpointRSV/MPV ID Kit01-1200022016-09-15
30014613330820D3 Fastpoint01-120002.B101-120002.B12018-07-22
30014613330837D3 Fastpoint01-120002.B201-120002.B22018-07-22
30014613336143SolanaM306M3062018-08-07
30014613338659D301-002007b01-002007b2019-04-23
30014613340119Savanna20445204452024-04-30
30014613340485SavannaM409-1M409-12024-04-30
30014613340492SavannaM409-4M409-42024-04-30

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
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
20816101025569Simplexa™ Group A Strep DirectDIASORIN MOLECULAR LLCPGX2016-09-22
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