IMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-D

Basic Information

• Brand Name: IMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-D
• Primary DI: 00630414964416
• Version / Model: 10381389
• Catalog Number: LKPD1
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• Labeler DUNS: 296822794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 3
• Public Version Date: 2022-04-29
• Public Version Status: Update
• Public Device Record Key: 63133a7e-7698-4ff2-b02d-9c752cce8b41

Device Description

Pyrilinks-D - IMMULITE - RGT - 100 Tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JMM	COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE	Clinical Chemistry	862.1400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61993	Collagen pyridium crosslink IVD, kit, chemiluminescent immunoassay	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414964416	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K980833	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius