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QuikRead go® Instrument

FDA UDI

Class I (US FDA UDI)

by Aidian Oy

Identity

Trade Name
QuikRead go® Instrument FDA UDI
Generic Name
Photometric/spectroscopic immunoassay analyser IVD FDA UDI
Device Name
QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. FDA UDI
Model / Reference
145218 FDA UDI
Description
QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. FDA UDI

Identifiers

Catalog Number
145218 FDA UDI
Primary DI / UDI-DI
06438115000198 FDA UDI
510(k) Number
K142993 FDA UDI
FDA Product Code
JJQ FDA UDI
GMDN Term
Photometric/spectroscopic immunoassay analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Photometric/spectroscopic immunoassay analyser IVD

QuikRead go® Instrument by Aidian Oy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Photometric/spectroscopic immunoassay analyser IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aidian Oy

Sources (1)

  • FDA UDI c18524c1-7078-4fbf-b950-5e3c1df8abf5 37 fields · synced May 30, 2026