AccessGUDID - DEVICE: ADVIA® Chemistry TCA (00630414551036)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry TCA
Version or Model: 10283014
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6520218
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414551036
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Tricyclic Antidepressants - 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?
60993	Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFH	U.V. SPECTROMETRY, TRICYCLIC ANTIDEPRESSANT DRUGS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961393	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: ebbc0a9c-3e2d-4b88-a7c8-788381c26284
Public Version Date: February 10, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016