Access Intact PTH Calibrators A16953

GUDID 15099590201920

The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter, Inc.

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590201920
• NIH Device Record Key: f79b2ecc-5b29-4b51-ae6f-5e6bf2c8b8e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Intact PTH Calibrators
• Version Model Number: A16953
• Catalog Number: A16953
• 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	15099590201920 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061190

FDA Product Code

• JIT: Calibrator, Secondary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-09

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