Auto-LiPA 48

GUDID 05414470806287

Instrument

Fujirebio Europe

Blot processor IVD

• Primary Device ID: 05414470806287
• NIH Device Record Key: 8c2714de-13a3-4614-bd3d-a8f8ee2f66c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auto-LiPA 48
• Version Model Number: 80628
• Company DUNS: 297346645
• Company Name: Fujirebio Europe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com
• Phone: +32093291329
• Email: info@fujirebio.com

Device Dimensions

• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch
• Length: 31 Inch
• Width: 18 Inch
• Height: 18 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414470806287 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

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: 2020-03-03
• Device Publish Date: 2020-02-24

Devices Manufactured by Fujirebio Europe

• 05414470804214 - TENDIGO Disposable Trays: 2022-09-22 Disposable Trays 5 trays per base unit
• 05414470804122 - TENDIGO: 2020-03-03 Instrument
• 05414470806287 - Auto-LiPA 48: 2020-03-03Instrument
• 05414470806287 - Auto-LiPA 48: 2020-03-03 Instrument
• 05414470806294 - Auto-LIA 48: 2020-03-03 Instrument