FDA.reportPublic FDA data

MicroVue

Primary DI
30014613335580
Brand
MicroVue
Company
QUIDEL CORPORATION
Model
C1-Inhibitor
Catalog number
A037
Device description
MicroVue C1-Inhibitor Plus 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
DBACOMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872426000CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAYCytotech, Inc.1987-07-23DBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613335580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333558030014613335580

GMDN Terms#

Term, Definition table
TermDefinition
Complement component C1 inhibitor IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of complement cascade component C1 inhibitor in a clinical specimen.

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
B1761350Antiserum to Human C1 Esterase InhibitorKENT LABORATORIES INCDBA2016-09-24
05051700010504Human C1 Inactivator BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDBA2016-09-24
05051700016674Human C1 Inactivator Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDBA2016-09-24
05051700017589Optilite C1 Inactivator KitTHE BINDING SITE GROUP LIMITEDDBA2016-09-24
00842768006302DImension Vista® C1 Inhibitor Flex® Reagent CartridgeSiemens Healthcare Diagnostics Products GmbHDBA2016-09-24
00842768007323N Antiserum to Human C1-InhibitorSiemens Healthcare Diagnostics Products GmbHDBA2016-09-24