PATHFAST 300646

GUDID 04987595300646

LSI MEDIENCE CORPORATION

Chemiluminescent immunoassay analyser IVD

• Primary Device ID: 04987595300646
• NIH Device Record Key: bdb1b89b-49ce-4502-b3a4-0fb76b79ae2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATHFAST
• Version Model Number: N/A
• Catalog Number: 300646
• Company DUNS: 691093090
• Company Name: LSI MEDIENCE CORPORATION
• 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: false
• 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	04987595300646 [Primary]
GS1	14987595300643 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), 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: 2023-06-20
• Device Publish Date: 2023-06-12

Devices Manufactured by LSI MEDIENCE CORPORATION

• 04987595300646 - PATHFAST: 2023-06-20
• 04987595300646 - PATHFAST: 2023-06-20
• 04987595301131 - PATHFAST cTnI-II: 2018-07-06
• 04987595301230 - PATHFAST Myo-II: 2018-07-06
• 04987595301339 - PATHFAST CK-MB-II: 2018-07-06
• 04987595301636 - PATHFAST NTproBNP: 2018-07-06
• 04987595301742 - PATHFAST hsCRP: 2018-07-06
• 04987595301537 - PATHFAST D-Dimer: 2018-03-29