AccessGUDID - DEVICE: ATELLICA IM ELF KIT (00630414618463)

GUDID

Device Identifier (DI) Information

Brand Name: ATELLICA IM ELF KIT
Version or Model: 11208118
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11208118
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414618463
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 KIT

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?
60994	Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens or markers associated with liver fibrosis in a clinical specimen, using a chemiluminescent immunoassay method. 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
QQB	Prognostic test for assessment of liver related disease progression

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190056	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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6399f983-3331-446c-8b58-3c479f8fc547
Public Version Date: March 23, 2023
Public Version Number: 1
DI Record Publish Date: March 15, 2023