Albumin BCP (6x50 mL) C22856

GUDID 08058056681980

The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only.

SENTINEL CH. SPA

Albumin IVD, reagent

• Primary Device ID: 08058056681980
• NIH Device Record Key: 8ab4ae46-0b85-4cba-afa9-43cf96c9cda3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Albumin BCP (6x50 mL)
• Version Model Number: C22856
• Catalog Number: C22856
• Company DUNS: 429572365
• Company Name: SENTINEL CH. SPA
• 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: 9999999999
• Email: customerservice@sentinel.it

Device Dimensions

• Total Volume: 300 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between 15 and 30 degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058056681980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193001

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-03
• Device Publish Date: 2020-02-24

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