GENCHEM™ Total Bilirubin Reagent GEN-TBILI R1

GUDID 00851445007266

TOTAL BILIRUBIN R1

GENCHEM INC

Total bilirubin IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00851445007266
• NIH Device Record Key: 4491ee76-a2ec-4dd1-8a97-9ddb3fb4123c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENCHEM™ Total Bilirubin Reagent
• Version Model Number: GEN-TBILI R1
• Catalog Number: GEN-TBILI R1
• 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	00851445007266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003892

FDA Product Code

• CIG: DIAZO COLORIMETRY, BILIRUBIN

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™ Total Bilirubin Reagent]

• 00851445007280: TOTAL BILIRUBIN R3
• 00851445007273: TOTAL BILIRUBIN R2
• 00851445007266: TOTAL BILIRUBIN R1