AccessGUDID - DEVICE: ARK™ Oxcarbazepine Metabolite Control (00858724003322)

GUDID

Device Identifier (DI) Information

Brand Name: ARK™ Oxcarbazepine Metabolite Control
Version or Model: 5032-0003-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5032-0003-00
Company Name: ARK DIAGNOSTICS INC

Primary DI Number: 00858724003322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 164880598 *Terms of Use

Device Description: The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended for use in quality control of the ARK™ Oxcarbazepine Metabolite Assay.

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:	Yes
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?
61981	Multiple anticonvulsant therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple anticonvulsant drugs, also known as antiepileptic drugs which may include carbamazepine, lamotrigine, phenytoin, and primidone, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153596	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: b656cb64-f90e-4c7a-a600-681e1c5bcbf1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016