Access Ostase Calibrators B83876

GUDID 15099590677381

The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP)

Beckman Coulter, Inc.

Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590677381
• NIH Device Record Key: ba0c70af-28b5-4b65-94b1-16760fd6e86c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Ostase Calibrators
• Version Model Number: B83876
• Catalog Number: B83876
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590677381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994278

FDA Product Code

• JIS: Calibrator, Primary

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: 2018-04-09
• Device Publish Date: 2016-09-09

On-Brand Devices [Access Ostase Calibrators]

• 15099590677381: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantita
• 15099590232306: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantita