aLF Reader 9002764

GUDID 04053228034469

photometric reader for scanning and interpretation of immunochromatographic assays

QIAGEN GmbH

Photometric immunoassay analyser IVD

• Primary Device ID: 04053228034469
• NIH Device Record Key: 4dbe3141-e266-4717-b64b-c3f75996bacc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aLF Reader
• Version Model Number: 1
• Catalog Number: 9002764
• Company DUNS: 317103745
• Company Name: QIAGEN GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228034469 [Primary]

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-23
• Device Publish Date: 2019-04-15

Devices Manufactured by QIAGEN GmbH

• 04053228035725 - therascreen® BRAF RGQ PCR Kit: 2025-06-09 The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene
• 04053228048381 - QIAstat-Dx® GI Panel 2 Mini B: 2025-04-07
• 04053228049166 - QIAstat-Dx® GI Panel 2 Mini B&V: 2025-02-26
• 04053228048862 - QIAstat-Dx® Respiratory Panel Mini: 2024-12-13
• 04053228003526 - QIAGEN Buffer ASL®: 2024-10-08 Stool Lysis Buffer
• 04053228048268 - QIAsymphony® DSP Circulating DNA Maxi Kit (192): 2024-10-08
• 04053228048350 - QIAsymphony® DSP Circulating DNA Kit (96): 2024-10-08
• 04053228048770 - QIAcuityDx® Four: 2024-10-08 The QIAcuityDx® Four is an automated digital PCR (dPCR) instrument designed to perform amplification, detection (qualitative an