AccessGUDID - DEVICE: Atellica IM CA 125II Calibrator (00630414598109)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM CA 125II Calibrator
Version or Model: 10995483
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995483
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414598109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: CA 125II Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL

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?
38231	Cancer antigen 125 (CA125) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LTK	TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020828	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: d29fadb0-ebc8-4dae-a05a-848b72dcee9f
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: December 22, 2017