L-Type HDL-C Reagent 2 993-72691

GUDID 10856626006097

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

High-density lipoprotein (HDL) cholesterol IVD, calibrator

• Primary Device ID: 10856626006097
• NIH Device Record Key: 9767367e-c3ba-4bb2-8198-8c3a0e88cbb7
• Commercial Distribution Discontinuation: 2020-10-23
• Commercial Distribution Status: Not 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: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.com
• Phone: 877-714-1924
• Email: diagnostics@wakousa.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. 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856626006090 [Unit of Use]
GS1	10856626006097 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-10-26
• Device Publish Date: 2016-11-23

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

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