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aLF Reader

FDA UDI

Class I (US FDA UDI)

by Qiagen, Inc.

Identity

Trade Name
aLF Reader FDA UDI
Generic Name
Photometric/spectroscopic immunoassay analyser IVD FDA UDI
Device Name
photometric reader for scanning and interpretation of immunochromatographic assays FDA UDI
Model / Reference
1 FDA UDI
Description
photometric reader for scanning and interpretation of immunochromatographic assays FDA UDI

Identifiers

Catalog Number
9002764 FDA UDI
Primary DI / UDI-DI
04053228034469 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

No

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

Category: Photometric/spectroscopic immunoassay analyser IVD

aLF Reader by Qiagen, Inc. — 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
Qiagen, Inc.

Sources (1)

  • FDA UDI 4dbe3141-e266-4717-b64b-c3f75996bacc 34 fields · synced Jun 8, 2026