← Back to catalogue

iPeak® reader 4, 3" Lateral Flow Reader

FDA UDI

Class I (US FDA UDI)

by Iul Sa

Identity

Trade Name
iPeak® reader 4,3" Lateral Flow Reader FDA UDI
Generic Name
Photometric/spectroscopic immunoassay analyser IVD FDA UDI
Device Name
The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.x) 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. FDA UDI
Model / Reference
100033000US1 FDA UDI
Description
The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.x) 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. FDA UDI

Identifiers

Catalog Number
900033000US / 900033000US2 FDA UDI
Primary DI / UDI-DI
08437022431482 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 126.5 Millimeter FDA UDI
Length — 145.0 Millimeter FDA UDI
Height — 140.0 Millimeter FDA UDI
Weight — 0.60 Kilogram FDA UDI

Category: Photometric/spectroscopic immunoassay analyser IVD

iPeak® reader 4, 3" Lateral Flow Reader by Iul Sa — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Iul Sa

Sources (1)

  • FDA UDI dab5f5e3-ab17-459d-a400-3cd748973d6b 37 fields · synced Jun 1, 2026