AccessGUDID - DEVICE: ADVIA® Chemistry CYSC Cystatin-C Calibrators (00630414561578)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry CYSC Cystatin-C Calibrators
Version or Model: 10376487
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10376487
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414561578
Issuing Agency: GS1
Commercial Distribution End Date: March 03, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Cystatin C - ADVIA Chem. - CAL - 5x2mL

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?
48174	Cystatin C IVD, calibrator	A material which is used to establish known points of reference for an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	CALIBRATOR, SECONDARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083906	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: 40bc55ec-d8c4-4258-8f2d-ef929447b7d4
Public Version Date: March 04, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016