IUL SA

Address:Ciutat Asuncion 4,Barcelona,ES

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1)

Premarket Exempt

Yes

Clear

iPeak® reader 4,3" Lateral Flow Reader - 08437022431482 Catalog Number : 900033000US1

Device Description : The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.0) is an instrument spe The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.0) is an instrument specifically to be used to provide quantitative, semi-quantitative, and/or qualitative in-vitro determination of photometric immunochromatographic test defined and marketed by IUL’ partners. The iPeak® reader 4,3” is intended to be used only in combination with lateral flow (LF) tests indicated for use with the iPeak® reader 4,3”, and only for applications that are described in the respective handbooks of our reader associates.

Device Class : 1

Duns Number: 468283860

Premarket Exempt : Yes

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

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