FDA.reportPublic FDA data

First Check

Primary DI
00643281061553
Brand
First Check
Company
FIRST CHECK DIAGNOSTIC CORP.
Model
One Drug Marijuana
Catalog number
THC
Device description
First Check Home Drug Test One Drug Marijuana
Published
2016-06-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDJEnzyme Immunoassay, Cannabinoids
NFWTest, Cannabinoid, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052115000FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASYFirst Check Diagnostics, LLC2005-12-29DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643281061553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643281061553006432810615536432810615530643281061553

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid 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 in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-788-5716info@firstcheckfamily.com

Regulatory Flags#

DUNS number
945331317
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643281801128First CheckTHC Test- 2 pack2019-09-06
00643281069078First Check7 Drug Test2016-06-30
00643281067555First Check2 Drug Test2016-06-30
00643281069047First Check4 Drug Test2016-06-30
00643281710055First Check(R)14 Drug Test2018-04-11
00643281069122First Check12 Drug Test2016-06-30
00643881069078First Check7 Drug Test2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
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10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
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