AccessGUDID - DEVICE: First Check (00643281061553)

GUDID

Device Identifier (DI) Information

Brand Name: First Check
Version or Model: One Drug Marijuana
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: THC
Company Name: FIRST CHECK DIAGNOSTIC CORP.

Primary DI Number: 00643281061553
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 945331317 *Terms of Use

Device Description: First Check Home Drug Test One Drug Marijuana

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):	Yes
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?
55550	Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDJ	Enzyme Immunoassay, Cannabinoids
NFW	Test, Cannabinoid, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052115	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 40 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b0018d0f-3ea6-4f22-b23a-222f1a598d43
Public Version Date: November 28, 2022
Public Version Number: 6
DI Record Publish Date: June 22, 2016