FDA.reportPublic FDA data

MicroVue

Primary DI
30014613335566
Brand
MicroVue
Company
QUIDEL CORPORATION
Model
CH50 Eq EIA
Catalog number
A018
Device description
MicroVue CH50 Eq 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
DAECOMPLEMENT C9, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAEComplement C9, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974111000QUIDEL CH50 EQ EIAQuidel Corp.1998-07-29DAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613335566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333556630014613335566

GMDN Terms#

Term, Definition table
TermDefinition
Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of total complement activity (CH50) 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
05051700021098Optilite® CH50 ReagentTHE BINDING SITE GROUP LIMITEDDAE2024-11-20
04987481164406Autokit CH50FUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2020-10-23
00498748116440Autokit CH50FUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2020-10-23
04987481164512CH50 CalibratorFUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2020-10-23
00856626006151CH50 CalibratorFUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2016-12-07
00856626006113Autokit CH50FUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2016-11-11
05051700010269Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700010276Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700010283Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700012294CH50 Eq Enzyme Immunoassay KitTHE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700015592Human CH50 Reagent pack for use on the SPAPLUSTHE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700018210Optilite CH50 ReagentTHE BINDING SITE GROUP LIMITEDDAE2016-09-24