FDA.reportPublic FDA data

Solana

Primary DI
30014613336167
Brand
Solana
Company
DIAGNOSTIC HYBRIDS, INC.
Model
M308
Catalog number
M308
Device description
Solana Bordetella Complete
Published
2020-02-04
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
OZZBordetella pertussis dna assay system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZZBordetella Pertussis Dna Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181029000Solana Bordetella Complete AssayQuidel Corporation2018-07-15OZZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613336167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333616730014613336167

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Bordetella species 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 one or multiple species of Bordetella bacteria, which may include B. pertussis, B. parapertussis and/or B. bronchiseptica 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
00875197007350cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.OZZ2026-02-23
00875197007367cobas liat Bordetella panel control kitRoche Molecular Systems, Inc.OZZ2026-02-23
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZZ2024-05-03
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZZ2023-04-06
00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OZZ2020-01-10
00840487101612Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOZZ2019-12-05
00840487101667Respiratory Pathogens Flex (RP Flex) Extraction TrayLUMINEX CORPORATIONOZZ2019-12-05
00840487101711Respiratory Pathogens Flex (RP Flex) Amplification TrayLUMINEX CORPORATIONOZZ2019-12-05
04053228033905QIAstat-Dx® Respiratory PanelQIAGEN GmbHOZZ2019-05-24
00840733102141Alethia™ Pertussis External Control KitMERIDIAN BIOSCIENCE, INC.OZZ2019-01-08
00840733102226Alethia™ PertussisMERIDIAN BIOSCIENCE, INC.OZZ2019-01-08
20816101025620Simplexa™ Bordetella DirectDIASORIN MOLECULAR LLCOZZ2018-08-24
20816101025637Simplexa™ Bordetella Positive Control PackDIASORIN MOLECULAR LLCOZZ2018-08-24
00815381020154FilmArray® Respiratory Panel 2 (RP2)BIOFIRE DIAGNOSTICS, LLCOZZ2017-07-18
00815381020161FilmArray® Respiratory Panel 2 (RP2)BIOFIRE DIAGNOSTICS, LLCOZZ2017-07-18
B178GBBORD100Bordetella Direct TestGREAT BASIN SCIENTIFIC, INC.OZZ2017-07-12
00840487101452ARIES® Bordetella AssayLUMINEX CORPORATIONOZZ2017-05-09
00815381020147FilmArray® Respiratory Panel (RP) EZBIOFIRE DIAGNOSTICS, LLCOZZ2016-12-06
00840733101137illumigene Pertussis External Control KitMERIDIAN BIOSCIENCE, INC.OZZ2016-09-23
00840733101199illumigene PertussisMERIDIAN BIOSCIENCE, INC.OZZ2016-09-23
00857573006164Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test CartridgeNANOSPHERE, INC.OZZ2016-09-23
00857573006263Respiratory Pathogens Flex (RP Flex) Extraction TrayNANOSPHERE, INC.OZZ2016-09-23
00857573006324Respiratory Pathogens Flex (RP Flex) Amplification TrayNANOSPHERE, INC.OZZ2016-09-23
00815381020062FilmArray® Respiratory Panel (RP)BIOFIRE DIAGNOSTICS, LLCOZZ2016-09-23
00815381020079FilmArray® Respiratory Panel (RP)BIOFIRE DIAGNOSTICS, LLCOZZ2016-09-23
30014613312093AmpliVueQUIDEL CORPORATIONOZZ2016-09-15