AccessGUDID - DEVICE: ARK™ Methotrexate II Control (00812101031193)

GUDID

Device Identifier (DI) Information

Brand Name: ARK™ Methotrexate II Control
Version or Model: 5071-0003-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5071-0003-00
Company Name: ARK DIAGNOSTICS INC

Primary DI Number: 00812101031193
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 164880598 *Terms of Use

Device Description: ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II 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:	No
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?
38535	Methotrexate 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 the antineoplastic drug methotrexate in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAO	Enzyme Immunoassay, Methotrexate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232017	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: 08643fa8-815e-4a54-a1f5-d89cde1dcd11
Public Version Date: November 01, 2024
Public Version Number: 1
DI Record Publish Date: October 24, 2024