AccessGUDID - DEVICE: QTEST 12 (25 Pack) (10864040000348)

GUDID

Device Identifier (DI) Information

Brand Name: QTEST 12 (25 Pack)
Version or Model: DOA-12C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIMPEX UNITED, INC

Primary DI Number: 10864040000348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130991479 *Terms of Use

Device Description: Qtest 12 (25 pack) - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50

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):	No
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?
55463	Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of drug and/or toxicology screen adulteration of a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs
LCM	Enzyme Immunoassay, Phencyclidine
DJG	Enzyme Immunoassay, Opiates
DJR	Enzyme Immunoassay, Methadone
DJC	Thin Layer Chromatography, Methamphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ	Enzyme Immunoassay, Cannabinoids
JXM	Enzyme Immunoassay, Benzodiazepine
DIS	Enzyme Immunoassay, Barbiturate
DKZ	Enzyme Immunoassay, Amphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071489	000
K122064	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5874d266-37e0-4ec0-8caf-5ff7fd9e4b6f
Public Version Date: July 06, 2023
Public Version Number: 5
DI Record Publish Date: September 30, 2016