Pyrilinks-D - IMMULITE - RGT - 200 Tests

Pyrilinks
IMMULITE® 2000 Systems DPD Pyrlinks-D - 10381461

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the pyridium crosslinks of collagen, deoxypyridinoline (DPD) and/or pyridinoline (PYD), in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used as a specific marker of bone resorption and osteoclastic activity to help in the diagnosis of bone disease (e.g., postmenopausal osteoporosis, bone metastasis, and Paget's disease) or in monitoring collagen resorption changes in patients receiving antiresorptive therapy.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JMM

Device Name: Column Chromatography & Color Development, Hydroxyproline

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1400

Third Party Flag: N

Medical Specialty: CH

Device Id: 00630414961859

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A