FDA.reportPublic FDA data

QuickVue

Primary DI
30014613201090
Brand
QuickVue
Company
QUIDEL CORPORATION
Model
One-Step hCG Urine Test
Catalog number
20109
Device description
QkVue hCG Urine 25T
Published
2016-09-15
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
JHIVisual, pregnancy hCG, prescription use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020799000QUICKVUE ONE-STEP HCG-URINEQuidel Corp.2002-05-17JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50014613201094PackageGS112In Commercial Distribution
50014613201940PackageGS112In Commercial Distribution
30014613201090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5001461320109450014613201094
5001461320194050014613201940
3001461320109030014613201090

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, 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.

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
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
30014613202981Sofia20298202982018-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936983113793Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)Hangzhou AllTest Biotech Co., Ltd.JHI2026-04-22
06936983113809Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)Hangzhou AllTest Biotech Co., Ltd.JHI2026-04-22
06970640093103INNOVITAInnovita (Tangshan) Biological Technology Co., Ltd.JHI2026-04-15
10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-04-09
00810164510105Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
80810164510101Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-02-12
00816862027723HORMONElife™WONDFO USA CO., LTD.JHI2026-01-15
10850082766007QMedix™Diagnostic Automation, Inc.JHI2025-12-24
00850082766000QMedix™Diagnostic Automation, Inc.JHI2025-12-24
00816862028157HORMONElife™WONDFO USA CO., LTD.JHI2025-12-15
00816862028119HORMONElife™WONDFO USA CO., LTD.JHI2025-12-15
20612479280148McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
20612479280162McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479280134McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479280158McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
20612479279722MckessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
20612479279739McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
10612479279855MckessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
10612479279862McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
00661392055650LSL HEALTHCARELSL Industries, LLCJHI2025-06-06
06952062778165HCG Home Use Pregnancy Test Midstream (Colloidal Gold)ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDJHI2025-02-12
56952062778160HCG Home Use Pregnancy Test Midstream (Colloidal Gold)ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDJHI2025-02-12
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-12-19
00850054026651QMedix™Diagnostic Automation, Inc.JHI2024-06-25
20197344024992MedlineMEDLINE INDUSTRIES, INC.JHI2024-03-11
10197344024995MedlineMEDLINE INDUSTRIES, INC.JHI2024-03-11
10673486002409Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-01-16
10673486002379TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TESTTECO DIAGNOSTICSJHI2023-10-26
00816862023787PreviewWONDFO USA CO., LTD.JHI2023-08-03