HR Series NEFA-HR(2) Color Reagent B 991-34891

GUDID 04987481164628

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent Non-esterified fatty acid IVD, reagent

• Primary Device ID: 04987481164628
• NIH Device Record Key: 910cb21c-d278-4649-b5f7-94e1d1406ac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HR Series NEFA-HR(2) Color Reagent B
• Version Model Number: 991-34891
• Catalog Number: 991-34891
• Company DUNS: 690598875
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Device Count: 4
• 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: true
• 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: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987481164628 [Unit of Use]
GS1	14987481164625 [Primary]

FDA Product Code

• JLH: Titrimetric, Fatty Acids

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: 2021-06-09
• Device Publish Date: 2021-06-01

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• 04987481164659 - Complement Control: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164673 - Autokit Micro Albumin Control Set: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164536 - L-Type LDL-C Reagent 1: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164543 - L-Type LDL-C Reagent 2: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164604 - HR Series NEFA-HR(2) Color Reagent A: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164611 - HR Series NEFA-HR(2) Solvent A: 2021-06-09 In-Vitro Diagnostic Use