Kit, McVu PYD
MicroVue - PYD EIA
Device Description
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 an enzyme immunoassay (EIA) 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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 Identifiers
Device Id: 30014613333913
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
