FDA.reportPublic FDA data

FIRST SIGN®

Primary DI
00857338006637
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCECOII-564
Catalog number
FSCECOII-564
Device description
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure BZO/COC/mAMP/OPI/OXY/THC
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DKEReagents, Test, Tetrahydrocannabinol
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKEReagents, Test, TetrahydrocannabinolClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857338006637PrimaryGS10
00857338006729Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857338006637008573380066378573380066370857338006637
00857338006729008573380067298573380067290857338006729

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
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2020-05-29
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2019-02-12
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2018-03-30
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.JXM2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXM2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23