FDA.reportPublic FDA data

Sofia

Primary DI
30014613338772
Brand
Sofia
Company
QUIDEL CARDIOVASCULAR INC.
Model
20352
Catalog number
20352
Device description
Sofia 2 Campylobacter FIA
Published
2025-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LQPCAMPYLOBACTER SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQPCampylobacter Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211342000Sofia 2 Campylobacter FIAQuidel Corporation2021-11-23LQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50014613338776PackageGS112In Commercial Distribution
30014613338772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5001461333877650014613338776
3001461333877230014613338772

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Campylobacter species antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to one or multiple species of Campylobacter bacteria, which may include C. coli, C. fetus and C. jejuni in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze, Store out of direct sunlight
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
080890141
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
30014613337706Triage98200982002018-11-01
30014613337911Triage97000HS97000HS2018-11-01
30014613337935Triage97021HS97021HS2018-11-01
30014613337942Triage97022HS97022HS2018-11-01
30014613337980Triage98000XR98000XR2018-11-01
30014613338000Triage98100981002018-11-01
50014613338776Sofia20352203522025-11-18
30014613337041Triage98713EU98713EU2018-11-07
30014613337713Triage98201982012018-11-01
30014613337720Triage98202982022018-11-01
30014613337959Triage97300EU97300EU2018-11-01
30014613337966Triage97400EU97400EU2018-11-01
30014613337973Triage97500EU97500EU2018-11-01
30014613337997Triage98000XREU98000XREU2018-11-01
30014613338017Triage98100EU98100EU2018-11-01
30014613338024Triage98600EU98600EU2018-11-01
30014613338109Triage94600946002019-08-02
30014613338116Triage94613946132019-07-24
30014613338123Triage94614946142019-07-24
30014613337010Triage98013XR98013XR2018-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50014613338776SofiaQUIDEL CARDIOVASCULAR INC.LQP2025-11-18
05032384519583ProSpecT Campylobacter Microplate Assay 96 TestsOXOID LIMITEDLQP2024-06-20
00840733102387Curian CampyMERIDIAN BIOSCIENCE, INC.LQP2023-03-23
00840733101717PREMIER CAMPYMERIDIAN BIOSCIENCE, INC.LQP2020-09-01
00857031002486CAMPYLOBACTER CHEKTECHLAB, INC.LQP2019-08-06
00857031002578QuickVue TLI Campylobacter TestTECHLAB, INC.LQP2019-05-30
00857031002462CAMPYLOBACTER CHEKTECHLAB, INC.LQP2019-05-29
00857031002479CAMPYLOBACTER QUIK CHEKTECHLAB, INC.LQP2019-05-29
00857031002455CAMPYLOBACTER QUIK CHEKTECHLAB, INC.LQP2019-04-12
00840733101373ImmunoCard STAT! CAMPYMERIDIAN BIOSCIENCE, INC.LQP2018-08-06
00813545026288CAMPY (jcl) Latex 50 Test Kit SCIMEDX CORPORATIONLQP2016-09-21