AccessGUDID - DEVICE: Elecsys CA 199 Immunoassay (04015630904297)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys CA 199 Immunoassay
Version or Model: 11776193122
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11776193122
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630904297
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?
54573	Cancer antigen 19-9 (CA19-9) 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 19-9 (CA19-9) in a clinical specimen, using an enzyme immunoassay (EIA) method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NIG	SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050231	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: daf0a80c-4962-4d32-9338-fd3ffc7d30e9
Public Version Date: January 08, 2019
Public Version Number: 4
DI Record Publish Date: September 20, 2016