FDA.reportPublic FDA data

First Check

Primary DI
00643281067555
Brand
First Check
Company
FIRST CHECK DIAGNOSTIC CORP.
Model
2 Drug Test
Published
2016-06-30
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJEnzyme Immunoassay, Cannabinoids
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, 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
00643281067555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643281067555006432810675556432810675550643281067555

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

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
00643281061553First CheckOne Drug MarijuanaTHC2016-06-22
00643281069078First Check7 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
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
00311917077932WalgreensWALGREEN CO.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFY2026-10-13
10722066005511Rapid ResponseBTNX IncNFY2026-10-09
10722066005511Rapid ResponseBTNX IncNFW2026-10-09
10722066018979Rapid ResponseBTNX IncNFW2026-10-08
10722066018979Rapid ResponseBTNX IncNFY2026-10-08
10722066019013Rapid ResponseBTNX IncNFY2026-10-08
10722066019013Rapid ResponseBTNX IncNFW2026-10-08
10722066019020Rapid ResponseBTNX IncNFW2026-10-08
10722066019020Rapid ResponseBTNX IncNFY2026-10-08
10722066019037Rapid ResponseBTNX IncNFY2026-10-08
10722066019037Rapid ResponseBTNX IncNFW2026-10-08
10722066019044Rapid ResponseBTNX IncNFW2026-10-08
10722066019044Rapid ResponseBTNX IncNFY2026-10-08
10722066018955Rapid ResponseBTNX IncNFY2026-10-06
10722066018955Rapid ResponseBTNX IncNFW2026-10-06
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
06936983114011Alltest THC50 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
06936983114066Alltest COC150 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
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