Pointe Scientific, Inc. Total Protein OT928-576

GUDID 00811727015112

Pointe Scientific, Inc. Total Protein Reagent is for the quantitative determination of total protein concentration in serum. Packaged for use on Olympus Analyzers. 6 x 66ml, 6 x 30ml

POINTE SCIENTIFIC, INC.

Total protein IVD, reagent

• Primary Device ID: 00811727015112
• NIH Device Record Key: a3c174a2-f9f8-48e4-bdbb-e6873d154361
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointe Scientific, Inc. Total Protein
• Version Model Number: OT928-576
• Catalog Number: OT928-576
• 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: 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: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811727015112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K822468

FDA Product Code

• CEK: Biuret (Colorimetric), Total Protein

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: 2016-08-31

On-Brand Devices [Pointe Scientific, Inc. Total Protein]

• 00811727015112: Pointe Scientific, Inc. Total Protein Reagent is for the quantitative determination of total pro
• 00811727014832: Pointe Total Protein Reagent is for the quantitative determination of total protein concentratio
• 00811727013101: Total Protein Reagent is for the quantitative determination of total protein concentration in se
• 00811727012005: Pointe Scientific, Inc. Total Protein Reagent for the quantitative determination of total protei
• 00811727011992: Pointe Scientific, Inc. Total Protein Reagent for the quantitative determination of total protei
• 00811727011985: Pointe Scientific, Inc. Total Protein Reagent for the quantitative determination of total protei