FDA.reportPublic FDA data

FIRST SIGN®

Primary DI
00857338006576
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCWTH-25
Catalog number
FSCWTH-25
Device description
DOA Single Test Dip card, 25Pcs/Box; First Sign for HemosureTHC
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DKEReagents, Test, Tetrahydrocannabinol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKEReagents, Test, TetrahydrocannabinolClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857338006576PrimaryGS10
00841824101821Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857338006576008573380065768573380065760857338006576
00841824101821008418241018218418241018210841824101821

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid 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 cannabinoids 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806777541
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817763022527First Sign®FSCCUP-13124 W/AD7FSCCUP-13124 W/AD72024-10-16
00817763022510First Sign®FSCCUP-13124 W/AD7FSCCUP-13124 W/AD72024-10-16
00817763022831First SignFSCCUP-21124FSCCUP-211242023-07-05
00817763022824First SignFSCCUP-21124FSCCUP-211242023-07-05
00857338006217First SignF2-CT25CF2-CT25C2016-05-09
00857338006224First Sign®F1-CT25UF1-CT25U2016-08-01
00857338006262HEMOSUREF2-TC01F2-TC012017-06-30
00857338006330First Sign®F2-CT25CF2-CT25C2016-08-01
00817763021933First Sign®F1-ST25F1-D042017-11-08
00817763021964Ovultell®F5-OST20/2F5-OST20/22017-11-13
00817763022367First SignFSCDIP1464FSCDIP14642023-05-18
00817763020837FIRST SIGN®FSCDIPTH-25FSCDIPTH-252016-10-07
00817763022589FIRST SIGN®FSCDIP7364FSCDIP73642022-04-21
00817763022442FIRST SIGN®FSCDIP3384FSCDIP33842019-05-14
00817763022541First Sign®FSCDIP7164FSCDIP7164P2020-01-08
00817763022466First Sign®FSCCUP-13124 W/ADFSCCUP-13124 W/ADP2019-10-21
00817763022428FIRST SIGN®FSCCUP-3864FSCCUP-38642019-04-29
00857338006019Hemosure T1-CK30T1-CK302016-05-09
00857338006026HEMOSURE®T1-CK10T1-CK102016-08-01
00857338006033HEMOSURE®T1-CK25T1-CK252016-08-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10796918002430Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DKE2021-09-24
10796918002423INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300ALFA SCIENTIFIC DESIGNS, INC.DKE2021-07-29
10796918002416INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, TALFA SCIENTIFIC DESIGNS, INC.DKE2021-07-12
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKE2021-06-24
10796918002201INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300ALFA SCIENTIFIC DESIGNS, INC.DKE2021-04-21
10796918002195INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30ALFA SCIENTIFIC DESIGNS, INC.DKE2020-09-14
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2019-09-28
10796918002188INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-09-23
10796918002171INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-06-12
10796918002133INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-03
10796918002089INSTANT-VIEW Multi-Drugs of Abuse Urine TestALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-01
10796918002102Instant-View Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-29
10796918002058INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-26
10796918002065INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-26
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKE2019-03-11
10796918002041INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200ALFA SCIENTIFIC DESIGNS, INC.DKE2019-02-06
10796918002010INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2018-12-14
10796918002027INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test ALFA SCIENTIFIC DESIGNS, INC.DKE2018-12-14
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-10-29
10796918001983INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, THC, XTC ALFA SCIENTIFIC DESIGNS, INC.DKE2018-08-28
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2018-04-19
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-02-16
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2017-10-12