GENCHEM™ Albumin Reagent GEN-ALB

GUDID 00851445007006

ALBUMIN BCP

GENCHEM INC

Albumin IVD, reagent

• Primary Device ID: 00851445007006
• NIH Device Record Key: 05b19e65-5745-48ae-9ab7-0ac6da9c8727
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENCHEM™ Albumin Reagent
• Version Model Number: GEN-ALB
• Catalog Number: GEN-ALB
• Company DUNS: 193856866
• Company Name: GENCHEM INC
• Device Count: 1
• 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: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org
• Phone: +1(714)529-7125
• Email: lorlow@genchem.org

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851445007006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021636

FDA Product Code

• CJW: BROMCRESOL PURPLE DYE-BINDING, ALBUMIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [GENCHEM™ Albumin Reagent]

• 00851445007013: ALBUMIN BCG
• 00851445007006: ALBUMIN BCP