FDA.reportPublic FDA data

MicroVue

Primary DI
30014613335535
Brand
MicroVue
Company
QUIDEL CORPORATION
Model
CIC-C1q EIA
Catalog number
A001
Device description
MicroVue CIC-C1q EIA
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
DAKCOMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAKComplement C1q, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862649000CYTOTECH CIC ENZYME IMMUNOASSAYCytotech, Inc.1986-09-04DAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613335535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333553530014613335535

GMDN Terms#

Term, Definition table
TermDefinition
Complement component C1q IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C1q in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
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
08426950514190QUANTA Lite® C1q CIC ELISAINOVA DIAGNOSTICS, INC.DAK2026-04-20
B1761110Antiserum to Human C1qKENT LABORATORIES INCDAK2016-09-24
B1761112Anti Human Complement C1q FITCKENT LABORATORIES INCDAK2016-09-24
05051700010511Human Complement C1q BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDAK2016-09-24
00813545023737Scanlisa C1q Elisa 96 Test SCIMEDX CORPORATIONDAK2016-09-20
00813545023744C1q Plates & Calibrator Sets SCIMEDX CORPORATIONDAK2016-09-20
30014613335559MicroVueQUIDEL CORPORATIONDAK2016-09-15
EBUHEKCIC1CIC-C1q ELISA KitBühlmann Laboratories AGDAK2016-09-01