FDA.reportPublic FDA data

QuickVue

Primary DI
30014613202059
Brand
QuickVue
Company
QUIDEL CORPORATION
Model
iFOB Test
Catalog number
20205
Device description
QuickVue iFOB Test Dev Kit 100T
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
KHEREAGENT, OCCULT BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021423000INSTANT-VIEW FECAL OCCULT BLOOD RAPID TESTAlfa Scientific Designs, Inc.2002-06-17KHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50014613202053PackageGS16In Commercial Distribution
30014613202059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5001461320205350014613202053
3001461320205930014613202059

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin) 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. It is not intended to be used for self-testing.

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
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
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
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00816917027821OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2026-03-25
10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestTECO DIAGNOSTICSKHE2026-01-30
10722066011338Rapid ResponseBTNX IncKHE2026-01-02
20722066011335Rapid ResponseBTNX IncKHE2026-01-02
00816917027173OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2025-05-02
10722355002894hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
10722355002900hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
10722355003068hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
00850036464662Red TunicaRodimedi & Associates, Inc.KHE2025-03-14
20850036464666Red TunicaRodimedi & Associates, Inc.KHE2025-03-14
00816862025972WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
10816862025979WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
00816917026374OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2024-06-28
00850054026590QMedix™Diagnostic Automation, Inc.KHE2024-05-10
10023513132157Reese's ColoTestREESE PHARMACEUTICAL COMPANYKHE2024-04-26
00816917026244OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2024-02-19
10023513132140Reese's ColoTestREESE PHARMACEUTICAL COMPANYKHE2024-01-23
00816917026121OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2023-10-26
00810143620023GenaCheck Rapid Self-Test Kit for FOBGenabio Diagnostics Inc.KHE2023-10-06
10722066007102Rapid ResponseBTNX IncKHE2023-06-15
00722066004302Rapid ResponseBTNX IncKHE2023-06-15
00816917026015OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2023-03-14
00816917025728OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-04-18
00816917025704OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-04-08
00816917025681OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-03-28
00816917025582OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2021-12-20
30080196165142MedlineMEDLINE INDUSTRIES, INC.KHE2021-10-29
10080196165148MedlineMEDLINE INDUSTRIES, INC.KHE2021-10-29
00816917025506OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2021-10-14