AccessGUDID - DEVICE: DOA CONTROL 1 (05055273207897)

GUDID

Device Identifier (DI) Information

Brand Name: DOA CONTROL 1
Version or Model: DA3121
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DA3121
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273207897
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The Randox Multidrug Control Level 1 is intended for use in the Quality Control of Methamphetamine, Barbiturates, Cocaine, Methadone and Opiates assays.

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?
55461	Multiple drugs of abuse IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials
DIF	Drug Mixture Control Materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092266	000
K092268	000
K092272	000
K092274	000
K113747	000
K113751	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: Stable for 28 days at +2ºC to +8ºC once opened
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: d3febb13-225a-4f30-bbdc-ed608f481d37
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2016