FDA.reportPublic FDA data

First Sign®

Primary DI
00817763022541
Brand
First Sign®
Company
HEMOSURE INC.
Model
FSCDIP7164
Catalog number
FSCDIP7164P
Device description
DOA 6 in 1 Test Dip Card, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BUP/COC/mAMP/MDMA/MOR
Published
2020-01-08
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LAFGas Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763022541PrimaryGS10
00817763022534Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763022541008177630225418177630225410817763022541
00817763022534008177630225348177630225340817763022534

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
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000091QMedix™Diagnostic Automation, Inc.LAF2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LAF2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DKZ2026-09-24
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LAF2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLAF2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31