AccessGUDID - DEVICE: IMMULITE® Systems CEA Calibration Verification Material (00630414971179)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® Systems CEA Calibration Verification Material
Version or Model: 10373684
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LCECVM
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414971179
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: CEA CVM - IMMULITE - CONS

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):	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?
38173	Carcinoembryonic antigen (CEA) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143639	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 below -20 deg C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6bc8609c-c9d9-4566-b2da-363db8b0c5fe
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020