FDA.reportPublic FDA data

QuikRead go® Instrument

Primary DI
06438115000198
Brand
QuikRead go® Instrument
Company
Aidian Oy
Model
145218
Catalog number
145218
Device description
QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits.
Published
2016-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical 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
06438115000198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438115000198064381150001986438115000198

GMDN Terms#

Term, Definition table
TermDefinition
Photometric immunoassay analyser IVDA portable, electrically-powered instrument, intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument uses photometry to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by health professionals for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 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
DM exempt
true
Serial number
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
06438115000112QuikRead go® CRP Control set1452171452172016-06-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
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00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncJJQ2023-08-26
10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
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09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
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06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
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00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05