AccessGUDID - DEVICE: Valproic Acid ONLINE TDM Valproic Acid (04015630997954)

GUDID

Device Identifier (DI) Information

Brand Name: Valproic Acid ONLINE TDM Valproic Acid
Version or Model: 4642465190
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4642465190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630997954
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
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?
59053	Valproic acid 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 central nervous system drug valproic acid in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEG	ENZYME IMMUNOASSAY, VALPROIC ACID

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060690	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: 61816322-f4d3-4da4-9180-fa44e2778e01
Public Version Date: November 11, 2020
Public Version Number: 4
DI Record Publish Date: September 20, 2016