AccessGUDID - DEVICE: ADVIA® Chemistry Negative Drug Urine Calibrator (00630414505718)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry Negative Drug Urine Calibrator
Version or Model: 10313977
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 726433
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414505718
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Negative Drug Urine - ADVIA Chem. - CAL - 1x10mL

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?
55455	Multiple therapeutic drugs/drugs of abuse 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 multiple therapeutic drugs and drugs of abuse in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKB	CALIBRATORS, DRUG MIXTURE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983159	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: 251d9537-5dee-4808-9ad0-6099da17bd55
Public Version Date: March 16, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016