Elecsys Beta-CrossLaps/serum 09005773160

GUDID 07613336187012

Roche Diagnostics GmbH

Collagen type I cross-linked C-telopeptide IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336187012
• NIH Device Record Key: 86bde120-cf2a-4d2f-abca-b8ed692d62fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Beta-CrossLaps/serum
• Version Model Number: 09005773160
• Catalog Number: 09005773160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336187012 [Primary]

FDA Product Code

• JMM: COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE

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: 2021-10-11
• Device Publish Date: 2021-10-01

On-Brand Devices [Elecsys Beta-CrossLaps/serum]

• 07613336187012: 09005773160
• 07613336171561: 09005781190