AccessGUDID - DEVICE: Elecsys CrossLapsserum Immunoassay (04015630938902)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys CrossLapsserum Immunoassay
Version or Model: 11972308160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11972308160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630938902
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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):	Yes
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?
47420	Collagen type I cross-linked C-telopeptide IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of collagen type I cross-linked C-telopeptides and/or metabolites [e.g., beta-isomerized C-terminal telopeptide of type I collagen (beta-CTx)] in a clinical specimen, using a chemiluminescent immunoassay method. Collagen type I cross-linked C-telopeptide and metabolites are typically used to aid in the diagnosis of conditions associated with elevated bone lysis/resorption (e.g., multiple myeloma, osteolytic metastasis, osteoporosis, rheumatoid arthritis).	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 [?]
K993706	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: 927f83e4-e179-4d9a-8c68-ee9df590ec45
Public Version Date: December 08, 2021
Public Version Number: 4
DI Record Publish Date: September 20, 2016