FDA.reportPublic FDA data

MicroVue

Primary DI
30014613333920
Brand
MicroVue
Company
QUIDEL CORPORATION
Model
BAP EIA
Catalog number
8012
Device description
MicroVue BAP 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
CINELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CINElectrophoretic Separation, Alkaline Phosphatase IsoenzymesClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613333920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333392030014613333920

GMDN Terms#

Term, Definition table
TermDefinition
Bone alkaline phosphatase (BALP) 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 bone alkaline phosphatase (BALP) 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
05060169695801IDS-iSYS Ostase® BAPIMMUNODIAGNOSTIC SYSTEMS LIMITEDCIN2021-03-08
15099590232313Access OstaseBeckman Coulter, Inc.CIN2016-09-09
M52530580TITAN GEL Alkaline Phosphatase KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M52533480SPIFE ALP Separation EnhancerHELENA LABORATORIES CORPORATIONCIN2016-09-07
M52551020Alkaline Phosphatase Indolyl Blue Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255510310TITAN GEL Alkaline Phosphatase Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255520550SPIFE Alkaline Phosphatase Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255523950SPIFE Alkaline Phosphatase-20,40 Gel KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255526040SPIFE Alkaline Phosphatase Gel KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
06438115000082UniQ® PINP RIAAidian OyCIN2016-04-13
05060169690059Ostase®+ BAP EIA IMMUNODIAGNOSTIC SYSTEMS LIMITEDCIN2016-04-01