L-Type HDL-C Reagent 2 993-72691

GUDID 04987481164598

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

High-density lipoprotein (HDL) cholesterol IVD, calibrator

• Primary Device ID: 04987481164598
• NIH Device Record Key: 06d95a0e-7ba8-4dac-88a5-86581681f2a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-Type HDL-C Reagent 2
• Version Model Number: 993-72691
• Catalog Number: 993-72691
• Company DUNS: 690598875
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Device Count: 4
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C. Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.
• Special Storage Condition, Specify: Between 0 and 0 *Store 2-10C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987481164598 [Unit of Use]
GS1	10856626006097 [Previous]
GS1	14987481164595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963847

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: 2020-11-02
• Device Publish Date: 2020-10-23

On-Brand Devices [L-Type HDL-C Reagent 2]

• 10856626006097: In-Vitro Diagnostic Use
• 04987481164598: In-Vitro Diagnostic Use