FDA.reportPublic FDA data

Sofia

Primary DI
30014613337799
Brand
Sofia
Company
QUIDEL CORPORATION
Model
20319
Catalog number
20319
Device description
Sofia2 Lyme WB 25T, US
Published
2019-12-10
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
LSRREAGENT, BORRELIA SEROLOGICAL REAGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSRReagent, Borrelia Serological ReagentMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173496000Sofia 2 Lyme FIA, Sofia Lyme Control SetQuidel Corporation2018-08-30LSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50014613337793PackageGS112In Commercial Distribution
30014613337799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5001461333779350014613337793
3001461333779930014613337799

GMDN Terms#

Term, Definition table
TermDefinition
Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079509836
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
30014613339755Sofia 220405204052023-03-28
30014613201090QuickVueOne-Step hCG Urine Test201092016-09-15
30014613339083Sofia20374203742021-02-17
30014613339229Sofia20377203772021-02-17
30014613339373QuickVue20387203872021-02-17
30014613001782QuickVue+hCG S/U Test001782016-09-14
30014613001799QuickVue+hCG S/U Test001792016-09-14
30014613003434QuickVue In-Line00343003432018-11-10
30014613201083QuickVue20108201082018-11-10
30014613201106QuickVueOne-Step hCG Combo Test201102016-09-15
30014613201229QuickVue+20122201222018-11-10
30014613201250QuickVue20125201252018-11-10
30014613201939QuickVue20193201932018-11-10
30014613202011QuickVueiFOB Test202012016-09-15
30014613202059QuickVueiFOB Test202052016-09-15
30014613202189Sofia20218202182018-11-10
30014613202424Sofia20242202422018-11-10
30014613202547Sofia20254202542018-11-10
30014613202745Sofia20274202742018-11-10
30014613202981Sofia20298202982018-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845533002950Anti-Borrelia VlsE1/pepC10 IgG/IgMZEUS SCIENTIFIC, INC.LSR2026-02-18
00850049545259AccuDiag ™Diagnostic Automation, Inc.LSR2024-03-06
00850054026378QMedix™Diagnostic Automation, Inc.LSR2024-01-31
04048474028096B. burgdorferi IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028102Borrelia burgdorferi IgG (Lyme) ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028119Borrelia burgdorferi IgM (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
00840239028099B. burgdorferi IgG/IgM ELISADRG International IncLSR2023-08-24
00840239028105Borrelia burgdorferi IgG (Lyme) ELISADRG International IncLSR2023-08-24
00840239028112Borrelia burgdorferi IgM (Lyme) ELISA DRG International IncLSR2023-08-24
EVIRBTCFDK1Borrelia All-In-One ViraChip Deca KitViramed Biotech AGLSR2022-11-08
EVIRBTCFOK1Borrelia All-In-One ViraChip Test KitViramed Biotech AGLSR2022-11-08
B350GSD0110310Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-10-28
B350GSD0110250Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
B350GSD0110260Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
00845533001854ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test SystemZEUS SCIENTIFIC, INC.LSR2022-04-27
00894175000022AccuDiag ™ Diagnostic Automation, Inc.LSR2021-08-10
B350GSD0110270Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test KitGold Standard Diagnostics CorporationLSR2021-07-20
B350GSD0110220Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test KitGold Standard Diagnostics CorporationLSR2020-07-01
B350GSD0110230Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test KitGold Standard Diagnostics CorporationLSR2020-07-01
05391516746779Trinity BiotechCLARK LABORATORIES, INC.LSR2019-12-26
05391516746816Trinity BiotechCLARK LABORATORIES, INC.LSR2019-12-26
05391516747486Trinity BiotechCLARK LABORATORIES, INC.LSR2019-11-05
05391516746625MarDxCLARK LABORATORIES, INC.LSR2019-10-25
05391516747134Trinity BiotechCLARK LABORATORIES, INC.LSR2019-08-06
05391516747547Trinity BiotechCLARK LABORATORIES, INC.LSR2019-08-06
03610520506394BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-05-13
03610520506455BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-04-30
03610520506462BioPlex 2200BIO-RAD LABORATORIES, INC.LSR2019-04-30
30014613202981SofiaQUIDEL CORPORATIONLSR2018-08-07
B350GSD0110240Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2018-05-21