Exdia TRF Plus PD-FC20

GUDID 08800026300083

A reader for the Exdia cartridges (immunofluorescence assay).

Precision Biosensor Inc.

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care

• Primary Device ID: 08800026300083
• NIH Device Record Key: df668127-ebd9-4d7c-be0a-85b2a5510a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exdia TRF Plus
• Version Model Number: PD-FC20
• Catalog Number: PD-FC20
• Company DUNS: 688454363
• Company Name: Precision Biosensor Inc.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026300083 [Primary]

FDA Product Code

• JZT: Fluorometer

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: 2022-11-24
• Device Publish Date: 2022-11-16