AccessGUDID - DEVICE: ADVIA® Chemistry HDL/LDL Cholesterol Calibrator (00630414470313)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry HDL/LDL Cholesterol Calibrator
Version or Model: 10311918
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B03-4763-01
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414470313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HDL/LDL Cholesterol - ADVIA Chem. - CAL - 3x1mL

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?
53356	Multiple lipid analyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	CALIBRATOR, PRIMARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 5e5bb570-cb93-44e4-8a7d-1bfc9e23d375
Public Version Date: December 08, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016