Lumipulse G Substrate Solution

GUDID 04987270231197

FUJIREBIO INC.

Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD Chemiluminescent substrate reagent IVD

• Primary Device ID: 04987270231197
• NIH Device Record Key: 29d4cbf0-45e1-4175-be6d-8d1999efd1bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G Substrate Solution
• Version Model Number: 231197
• Company DUNS: 710873907
• Company Name: FUJIREBIO INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com
• Phone: 610-240-3800
• Email: customersupport@fdi.com

Device Dimensions

• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 600 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270231197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142895

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-09-16

Devices Manufactured by FUJIREBIO INC.

• 04987270234938 - Lumipulse G BRAHMS PCT Calibrator Set: 2023-05-04
• 04987270234945 - Lumipulse BRAHMS PCT Controls: 2023-05-04
• 04987270234884 - Lumipulse G B-Amyloid 1-42 Immunoreaction Calibrator Set: 2022-11-08
• 04987270234891 - Lumipulse G B-Amyloid 1-40 Calibrator Set: 2022-11-08
• 04987270234907 - Lumipulse B-Amyloid Controls: 2022-11-08
• 04987270230343 - Lumipulse G B-Amyloid 1-42 Immunoreaction Calibrator Set: 2022-03-22
• 04987270231432 - Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges: 2022-03-22
• 04987270231531 - Lumipulse G B-Amyloid 1-40 Calibrator Set: 2022-03-22