Lumipulse G TSH-III Calibrators

GUDID 04987270231135

FUJIREBIO INC.

Thyroid stimulating hormone (TSH) IVD, calibrator

• Primary Device ID: 04987270231135
• NIH Device Record Key: 2a2a3161-b047-4bf0-95d8-e6a0c323dc4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G TSH-III Calibrators
• Version Model Number: 231135
• Company DUNS: 710873907
• Company Name: FUJIREBIO 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: true
• 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
• 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

• 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
• Device Size Text, specify: 0

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
• 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	04987270231135 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-01

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