AccessGUDID - DEVICE: ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents (00630414474748)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents
Version or Model: 10309071
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3940010
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414474748
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: IBCT - ADVIA Chem. - RGT - 4x100/4x80 tests

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?
53904	Total iron binding capacity (TIBC) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of total iron binding capacity (TIBC) of a clinical specimen, using a spectrophotometry method. TIBC is determined by adding the values obtained for the concentration of serum iron and the available iron-binding capacity of transferrin [i.e., the unsaturated iron binding capacity (UIBC)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JMO	Ferrozine (colorimetric) iron binding capacity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000781	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
Special Storage Condition, Specify: Do not freeze
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: 8d8df6e5-349a-4b30-875a-c3b5805d092d
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020