Pointe Total Bilirubin Reagent 14-HB979-365

GUDID 00811727015952

Pointe Total Bilirubin Reagent packaged for use on the Mindray BS480. 5 x 58ml R1, 5 x 15ml R2. For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

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• Primary Device ID: 00811727015952
• NIH Device Record Key: 9251324b-53a5-4874-88d0-6d15373dab38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Total Bilirubin Reagent
• Version Model Number: 14-HB979-365
• Catalog Number: 14-HB979-365
• Company DUNS: 045623154
• Company Name: POINTE SCIENTIFIC, 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: true
• Device Combination Product: false
• Single Use: false
• 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: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com
• Phone: 800-445-9853
• Email: techservice@medtestdx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727015952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040391

FDA Product Code

• CIG: Diazo Colorimetry, Bilirubin

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: 2021-02-08
• Device Publish Date: 2021-01-30

On-Brand Devices [Pointe Total Bilirubin Reagent]

• 00811727016256: Pointe Total Bilirubin Reagent packaged for use on the Mindray BA800. 5 x 63ml R1, 5 x 16ml R2.
• 00811727015952: Pointe Total Bilirubin Reagent packaged for use on the Mindray BS480. 5 x 58ml R1, 5 x 15ml R2.