AccessGUDID - DEVICE: Atellica IM CA 19-9 (00630414598178)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM CA 19-9
Version or Model: 10995490
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995490
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414598178
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: CA 19-9 - Atellica IM - RGT 50T

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):	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?
60976	Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay	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 a chemiluminescent immunoassay 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 [?]
K031393	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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.
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: 6da9aed2-6511-4d01-b190-852047d78a28
Public Version Date: November 18, 2021
Public Version Number: 6
DI Record Publish Date: December 22, 2017