AccessGUDID - DEVICE: ADVIA® Chemistry THEO_2 Theophylline

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry THEO_2 Theophylline_2 Reagents
Version or Model: 10377503
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10377503
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414561905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Theophyline - ADVIA Chem. - RGT - 4x100 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?
59056	Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the anti-asthma drug theophylline in a clinical specimen, using and enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLS	ENZYME IMMUNOASSAY, THEOPHYLLINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913123	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, Avoid prolonged exposure to temperatures above 32°C
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: aafa5737-e9b8-4c59-ae43-19174dd35869
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016