FDA.reportPublic FDA data

MicroVue

Primary DI
30014613335559
Brand
MicroVue
Company
QUIDEL CORPORATION
Model
CIC-C1q Controls
Catalog number
A013
Device description
MicroVue CIC-C1q Ctrls
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613335559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333555930014613335559

GMDN Terms#

Term, Definition table
TermDefinition
Complement component C1q IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of complement cascade component C1q in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0-20 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
30014613335535MicroVueQUIDEL CORPORATIONDAK2016-09-15
EBUHEKCIC1CIC-C1q ELISA KitBühlmann Laboratories AGDAK2016-09-01