AccessGUDID - DEVICE: IMMULITE® 2000 Systems DPD Pyrlinks-D (00630414961859)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® 2000 Systems DPD Pyrlinks-D
Version or Model: 10381461
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L2KPD2
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414961859
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: Pyrilinks-D - IMMULITE - RGT - 200 Tests

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JMM	COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980833	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 793f8eab-f21c-4321-a857-86dd4939dcde
Public Version Date: March 22, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2020