FDA.reportPublic FDA data

Sofia

Primary DI
50014613338776
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
OTC
false
Sterile
false
Single use
false

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080890141
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
30014613338772Sofia20352203522025-11-18
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
30014613338772SofiaQUIDEL 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