L-Type LDL-C Reagent 1 999-00404

GUDID 04987481164536

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Low density lipoprotein (LDL) cholesterol IVD, reagent

• Primary Device ID: 04987481164536
• NIH Device Record Key: 74cf9f32-b3cd-49ce-ae11-a4c915cff38b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-Type LDL-C Reagent 1
• Version Model Number: 999-00404
• Catalog Number: 999-00404
• Company DUNS: 690598875
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Device Count: 2
• 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: 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	04987481164536 [Unit of Use]
GS1	14987481164533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982271

FDA Product Code

• LBR: Ldl & Vldl Precipitation, Hdl

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

Devices Manufactured by FUJIFILM WAKO PURE CHEMICAL CORPORATION

• 04987481164666 - Autokit Micro Albumin: 2021-08-09 In-Vitro Diagnostic Use
• 04987481164642 - NEFA Linearity Material: 2021-06-09 In-Vitro Diagnostic Use
• 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: 2021-06-09In-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