AccessGUDID - DEVICE: ARK™ Fentanyl II Assay (00812101030561)

GUDID

Device Identifier (DI) Information

Brand Name: ARK™ Fentanyl II Assay
Version or Model: 5069-0001-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5069-0001-00
Company Name: ARK DIAGNOSTICS INC

Primary DI Number: 00812101030561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 164880598 *Terms of Use

Device Description: The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.

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?
63018	Fentanyl 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 fentanyl in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJG	Enzyme Immunoassay, Opiates

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: d44789cd-0e9e-4cf5-954f-039f725a28cd
Public Version Date: March 06, 2020
Public Version Number: 1
DI Record Publish Date: February 27, 2020