FDA.reportPublic FDA data

QuickVue

Primary DI
30014613200062
Brand
QuickVue
Company
QUIDEL CORPORATION
Model
0B006
Catalog number
0B006
Device description
QkVue Chlamydia 25T
Published
2018-11-10
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
LJCENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K946276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946276000QUICKVUE(R) CHLAMYDIA TESTQuidel Corp.1995-05-19LJC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613200062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461320006230014613200062

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Chlamydia species antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple species of Chlamydia bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

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
30014613337799Sofia20319203192019-12-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290001913147SeroELISA Chlamydia IgGSAVYON DIAGNOSTICS LTDLJC2025-05-29
07290001913161SeroELISA Chlamydia IgASAVYON DIAGNOSTICS LTDLJC2025-05-29
05391516743952Trinity BiotechCLARK LABORATORIES, INC.LJC2017-05-07