FDA.reportPublic FDA data

First Sign®

Primary DI
00817763022169
Brand
First Sign®
Company
HEMOSURE INC.
Model
FSCDIPTC-25
Device description
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure, CLIA WaivedTCA
Published
2018-05-09
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
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763022169PrimaryGS10
00817763022176Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763022169008177630221698177630221690817763022169
00817763022176008177630221768177630221760817763022176

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.

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
00857338006576FIRST SIGN®FSCWTH-25FSCWTH-252016-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLFG2026-06-02
10850013035523Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850013035585Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850013035608Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2026-05-21
10850076289062Hysen Drug Test CupsHYSEN INC.LFG2026-03-18
10850076289000Hysen Drug Test CupsHYSEN INC.LFG2025-08-04
10850076289017Hysen Drug Test CardsHYSEN INC.LFG2025-08-04
10858886006848Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2025-01-17
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.LFG2024-02-09
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.LFG2023-11-30
10858886006824Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2023-10-20
10817038022174Number OneUCP BIOSCIENCES, INC.LFG2023-06-16
10850013035189Identify HealthMEDICAL DISTRIBUTION GROUP INCLFG2023-03-08
10858886006770Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2023-02-14
10796918002447Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.LFG2022-11-07
10850013035172Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCLFG2022-08-01
10858886006701Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-07-14
10858886006688Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-06-14
10858886006565Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLFG2022-04-28
10858886006572Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
10858886006596Noble Drug Test Cup (Urine)NOBLE MEDICAL INCLFG2022-04-28
20869419000230Express ResultsTM Quest DiagnosticsLFG2022-03-28
20869419000247Express ResultsTM Quest DiagnosticsLFG2022-03-28