AccessGUDID - DEVICE: First Check(R) (00643281710055)

GUDID

Device Identifier (DI) Information

Brand Name: First Check(R)
Version or Model: 14 Drug Test
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: FIRST CHECK DIAGNOSTIC CORP.

Primary DI Number: 00643281710055
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(R) Home Drug Test, 14 Drug

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?
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
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs
QAW	Test, Tricyclic Antidepressants, Over The Counter
JXN	Enzyme Immunoassay, Propoxyphene
QBF	Test, Propoxyphene, Over The Counter
LCM	Enzyme Immunoassay, Phencyclidine
NGM	Test, Phencyclidine (Pcp), Over The Counter
NGG	Test, Methamphetamine, Over The Counter
DJC	Thin Layer Chromatography, Methamphetamine
DJR	Enzyme Immunoassay, Methadone
PTG	Test, Methadone, Over The Counter
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
NFT	Test, Amphetamine, Over The Counter
DKZ	Enzyme Immunoassay, Amphetamine
PTH	Test, Barbiturate, Over The Counter
DIS	Enzyme Immunoassay, Barbiturate
NFV	Test, Benzodiazepine, Over The Counter
JXM	Enzyme Immunoassay, Benzodiazepine
NGI	Test, Morphine, Over The Counter
NGL	Test, Opiates, Over The Counter
DJG	Enzyme Immunoassay, Opiates
DNK	Thin Layer Chromatography, Morphine
NFW	Test, Cannabinoid, Over The Counter
LDJ	Enzyme Immunoassay, Cannabinoids

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122633	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 15 and 30 Degrees Celsius
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: da205c1e-980f-4757-9b2e-d787eb46500c
Public Version Date: June 10, 2022
Public Version Number: 7
DI Record Publish Date: April 11, 2018