AccessGUDID - DEVICE: ADVIA® Chemistry Wide Range C-Reactive Protein Calibrators (00630414475714)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry Wide Range C-Reactive Protein Calibrators
Version or Model: 10313256
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B03-4815-01
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414475714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: CRP (Wide Range) - ADVIA Chem. - CAL - 6x1mL

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?
41838	C-reactive protein (CRP) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	CALIBRATOR, PRIMARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022682	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: b9fe778e-40b2-4aca-9837-99712727ba24
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016