AccessGUDID - DEVICE: ADVIA® Chemistry TOX CAL 1 (00630414551050)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry TOX CAL 1
Version or Model: 10283016
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6520234
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414551050
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Serum Tox ibrator 1 - ADVIA Chem. - CAL - 1x5mL

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 [?]
K961372	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: 872e3ec4-0a41-4cc1-ab7a-08bd162e8b7b
Public Version Date: March 04, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2016