FDA.reportPublic FDA data

First Check

Primary DI
00643281801128
Brand
First Check
Company
FIRST CHECK DIAGNOSTIC CORP.
Model
THC Test- 2 pack
Published
2019-09-06
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
00643281801128PrimaryGS10
00643281990402Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643281801128006432818011286432818011280643281801128
00643281990402006432819904026432819904020643281990402

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
Handling 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
2
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643281061553First CheckOne Drug MarijuanaTHC2016-06-22
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
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06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
10722066005511Rapid ResponseBTNX IncNFW2026-10-09
10722066018979Rapid ResponseBTNX IncNFW2026-10-08
10722066019013Rapid ResponseBTNX IncNFW2026-10-08
10722066019020Rapid ResponseBTNX IncNFW2026-10-08
10722066019037Rapid ResponseBTNX IncNFW2026-10-08
10722066019044Rapid ResponseBTNX IncNFW2026-10-08
10722066018955Rapid ResponseBTNX IncNFW2026-10-06
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
10722066018696Rapid ResponseBTNX IncNFW2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFW2026-08-14
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
06936983114011Alltest THC50 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114165Alltest THC50 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114264Alltest THC50 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114448Alltest THC50 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114547Alltest THC50 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114691Alltest THC50 Home Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFW2026-04-16