Emit Cyclosporine Sample

GUDID 00869164000079

FUJIREBIO DIAGNOSTICS, INC.

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

• Primary Device ID: 00869164000079
• NIH Device Record Key: 406450ef-1b82-4f7f-9c7a-13b90cdd970a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emit Cyclosporine Sample
• Version Model Number: 4008086
• Company DUNS: 079291908
• Company Name: FUJIREBIO DIAGNOSTICS, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com
• Phone: 800-531-7963
• Email: kits@fdi.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869164000079 [Primary]

FDA Product Code

• MKW: Cyclosporine

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: 2023-12-14
• Device Publish Date: 2023-12-06

Devices Manufactured by FUJIREBIO DIAGNOSTICS, INC.

• 00869164000055 - Serodia TP-PA Kits: 2023-12-14 100 test kit
• 00869164000062 - Serodia TP-PA Kits: 2023-12-14 220 test kits
• 00869164000079 - Emit Cyclosporine Sample: 2023-12-14
• 00869164000079 - Emit Cyclosporine Sample: 2023-12-14
• 00869164000048 - Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool: 2022-03-22 Software
• 00869164000000 - MESOMARK: 2018-07-06
• 00869164000017 - Lumipulse G ROMA: 2018-07-06 Software Disk
• 00869164000024 - ROMA: 2018-07-06 ROMA (HE4 EIA + ARCHITECT CA125II) Software disk