AccessGUDID - DEVICE: ATELLICA IM ELF MCM SET (00630414618111)

GUDID

Device Identifier (DI) Information

Brand Name: ATELLICA IM ELF MCM SET
Version or Model: 11208708
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11208708
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414618111
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ATELLICA IM ELF MCM SET

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?
60996	Multiple liver fibrosis marker 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 multiple antigens or markers associated with liver fibrosis in a clinical specimen. The range of analytes detected may include, but is not limited to, hyaluronic acid (HA), procollagen type III N-terminal propeptide (PIIINP), tissue inhibitor of matrix metalloproteinase 1 (TIMP-1).	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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: 4e1c41af-5df3-4a9a-b71a-b1215a269b71
Public Version Date: March 23, 2023
Public Version Number: 1
DI Record Publish Date: March 15, 2023