AccessGUDID - DEVICE: Elecsys CA 15-3 II (07613336218334)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys CA 15-3 II
Version or Model: 09755594190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09755594190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336218334
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:	No
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?
54571	Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOI	System, test, immunological, antigen, tumor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181492	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce22adf9-61b1-4321-8ed2-6b70d86e9960
Public Version Date: August 07, 2024
Public Version Number: 1
DI Record Publish Date: July 30, 2024