FDA.reportPublic FDA data

QuikRead go® CRP Control set

Primary DI
06438115000112
Brand
QuikRead go® CRP Control set
Company
Aidian Oy
Model
145217
Catalog number
145217
Device description
QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go CRP assay with the QuikRead go Instrument.
Published
2016-06-01
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142993000QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstrumentOrion Diagnostica, OY2016-03-10DCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438115000112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438115000112064381150001126438115000112

GMDN Terms#

Term, Definition table
TermDefinition
C-reactive protein (CRP) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of C-reactive protein (CRP) 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
+358104261product.support@oriondiagnosti
+358103093000product.support@aidian.eu

Regulatory Flags#

DUNS number
401656868
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
06438115000099QuikRead go® CRP1452151452152016-06-01
06438115000105QuikRead go® CRP Verification set1452161452162016-06-01
06438115000198QuikRead go® Instrument1452181452182016-06-01
06438115000006Uricult® CLED+Polymyxin / MacConkey6801710032016-05-13
06438115000013Uricult® CLED+Polymyxin /EMB6801810022016-05-13
06438115000020Uricult® CLED/MacConkey6801910012016-05-13
06438115000037Uricult CLED/EMB6801410002016-05-13
06438115000044Uricult® Trio68197681972016-05-12
06438115000082UniQ® PINP RIA67034670342016-04-13

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