AccessGUDID - DEVICE: Verify (G474MV002100002EI0)

GUDID

Device Identifier (DI) Information

Brand Name: Verify
Version or Model: MV002.10.0002EI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mlife Diagnostics, LLC

Primary DI Number: G474MV002100002EI0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117581283 *Terms of Use

Device Description: mLife Verify 10 panel oral fluid drug test BAR BUP BZO COC FEN MET OPI OXY PCP THC

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:	No
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?
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test 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
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt
PVH	Test, Opiates, Employment And Insurance Testing, Exempt
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt
PVC	Test, Lsd, Employment And Insurance Testing, Exempt

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85086072-6279-497a-9582-913e64d9d3bd
Public Version Date: April 09, 2024
Public Version Number: 1
DI Record Publish Date: April 01, 2024