Access C-Peptide Calibrators

GUDID 15099590733360

The Access C-Peptide Calibrators are intended to calibrate the Access C-Peptide assay for the quantitative determination of C-peptide levels in human serum, plasma and urine using the Access Immunoassay Systems.

Beckman Coulter, Inc.

C-peptide IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590733360
• NIH Device Record Key: 44fd520c-3769-4d64-9d00-b9649361d994
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access C-Peptide Calibrators
• Version Model Number: C31860
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	15099590733360 [Primary]

FDA Product Code

• JIT: Calibrator, Secondary

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: 2023-08-07
• Device Publish Date: 2023-07-28

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