FDA.reportPublic FDA data

FIRST SIGN®

Primary DI
00857338006460
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCW124
Catalog number
FSCW124
Device description
DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure COC/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
Sterile
false
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
00857338006460PrimaryGS10
00841824100152Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857338006460008573380064608573380064600857338006460
00841824100152008418241001528418241001520841824100152

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817763022510First Sign®FSCCUP-13124 W/AD7FSCCUP-13124 W/AD72024-10-16
00817763022824First SignFSCCUP-21124FSCCUP-211242023-07-05
00817763022367First SignFSCDIP1464FSCDIP14642023-05-18
00817763022572FIRST SIGN®FSCDIP7364FSCDIP73642022-04-21
00817763022541First Sign®FSCDIP7164FSCDIP7164P2020-01-08
00817763022466First Sign®FSCCUP-13124 W/ADFSCCUP-13124 W/ADP2019-10-21
00817763022442FIRST SIGN®FSCDIP3384FSCDIP33842019-05-14
00817763022428FIRST SIGN®FSCCUP-3864FSCCUP-38642019-04-29
00817763020158FIRST SIGN®D0115TC-01D0115TC-012016-09-21
00817763020165FIRST SIGN®D0115TC-02D0115TC-022016-09-21
00857338006163HEMOSURE®T1-TC02T1-TC022016-08-24
00817763022244First Sign®FSCCUP-6664 W/AD72018-07-23
00817763022268First Sign®FSCCUP-20104 W/AD72018-07-23
00817763022220First Sign®FSCCUP-13124 W/AD82018-06-18
00817763022206First Sign®FSCDIP17242018-05-22
00817763022183First Sign®FSCDIP50542018-05-14
00817763022046First Sign®FSCDIPBA-252018-05-09
00817763022060First Sign®FSCDIPED-252018-05-09
00817763022084First Sign®FSCDIPMD-252018-05-09
00817763022107First Sign®FSCDIPMO-252018-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816036021625STATCUP®MICRO DISTRIBUTING, L.CDKE2021-12-01
00816036021588STATCUP®MICRO DISTRIBUTING, L.CDKE2021-10-18
00796918002426INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300ALFA SCIENTIFIC DESIGNS, INC.DKE2021-07-29
00796918002204INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300ALFA SCIENTIFIC DESIGNS, INC.DKE2021-04-21
00796918002198INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30ALFA SCIENTIFIC DESIGNS, INC.DKE2020-09-14
00816036021878FASTEST LABSMICRO DISTRIBUTING, L.CDKE2019-07-09
00816036026507STATCUP® MICRO DISTRIBUTING, L.CDKE2019-07-02
10796918002119INSTANT-VIEW Marijuana (THC) Urine Dip Cassette TestALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-03
10796918002126INSTANT-VIEW Marijuana (THC) Urine Dip Cassette TestALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-03
10796918002034INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test ALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-01
10796918002072INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-26
10766918002075INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-26
00816036021816STATCUP® IIMICRO DISTRIBUTING, L.CDKE2019-01-17
00812203030056GenericCHEMTRON BIOTECH INCDKE2018-10-26
10796918001938INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2018-08-28
10796918001945INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2018-08-28
10796918001952INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2018-08-28
00816036025012STATCUP® IIMICRO DISTRIBUTING, L.CDKE2017-10-23
10866415000335Speedy TestsSPEEDY SOLUTIONS LLCDKE2017-03-09
00895330002851Healgen (Private Label) 6125A3CONFIRM BIOSCIENCES, INC.DKE2017-01-19
10796918001891Instant-View Multi-Drugs of Abuse Dip Test AMP, COC, MET, MOR, THC, XTCALFA SCIENTIFIC DESIGNS, INC.DKE2017-01-03
10796918001884INSTANT-VIEW Multi-Drugs of Abuse Urine Test (AMP, BZD, COC, MET, MOR300, THC)ALFA SCIENTIFIC DESIGNS, INC.DKE2016-11-18
00817763021551FIRST SIGN®HEMOSURE INC.DKE2016-10-20
00817815020990CRL Stat ™CLINICAL REFERENCE LABORATORY, INC.DKE2016-10-14
00817763020837FIRST SIGN®HEMOSURE INC.DKE2016-10-07
10796918001853Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DKE2016-10-05
10796918001860Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI OXY PCP THCALFA SCIENTIFIC DESIGNS, INC.DKE2016-10-05
10796918001877Multi-Drug of Abuse Urine Cup Test AMP BAR BZD COC MET MOR/OPI MTD PCP PPX THCALFA SCIENTIFIC DESIGNS, INC.DKE2016-10-05
10796918001020INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, PCP, THCALFA SCIENTIFIC DESIGNS, INC.DKE2016-09-23
10796918001037INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THCALFA SCIENTIFIC DESIGNS, INC.DKE2016-09-23