FDA.reportPublic FDA data

First Sign®

Primary DI
00817763022107
Brand
First Sign®
Company
HEMOSURE INC.
Model
FSCDIPMO-25
Device description
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure, CLIA Waived MOR
Published
2018-05-09
Public version status
New
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
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763022107PrimaryGS10
00817763022114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763022107008177630221078177630221070817763022107
00817763022114008177630221148177630221140817763022114

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
00817763022121First Sign®FSCDIPMT-252018-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80810164510071Atida Fentanyl Drug of Abuse Test RxACESO LABORATORIES INC.DJG2026-03-23
10810173655979HealgenHealgen Scientific Limited Liability CompanyDJG2026-03-11
10810173655986HealgenHealgen Scientific Limited Liability CompanyDJG2026-03-11
10810173656037HealgenHealgen Scientific Limited Liability CompanyDJG2026-03-11
00850076346027HealgenHEALGEN LIFE SCIENCE, LLCDJG2026-02-06
10810173655627HealgenHealgen Scientific Limited Liability CompanyDJG2026-01-30
10810173655740HealgenHealgen Scientific Limited Liability CompanyDJG2026-01-30
00810173654814HealgenHealgen Scientific Limited Liability CompanyDJG2026-01-08
10810173652169HealgenHealgen Scientific Limited Liability CompanyDJG2025-12-19
10810173654132HealgenHealgen Scientific Limited Liability CompanyDJG2025-12-19
10810173654583Healgen Healgen Scientific Limited Liability CompanyDJG2025-12-19
00850624008643Fentanyl II Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2025-11-17
00850013037001Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2025-10-31
10815845024237SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJG2024-12-17
10815845024268SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJG2024-12-17
10815845024398SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJG2024-12-17
00812101031001DRI Tramadol Assay - 500 mLARK DIAGNOSTICS INCDJG2024-11-14
00812101031018DRI Tramadol Assay - 115mLARK DIAGNOSTICS INCDJG2024-11-14
00812101031025DRI Tramadol Negative Calibrator KitARK DIAGNOSTICS INCDJG2024-11-14
00812101031032DRI Tramadol Cutoff Calibrator KitARK DIAGNOSTICS INCDJG2024-11-14
00812101031049DRI Tramadol Calibrator KitARK DIAGNOSTICS INCDJG2024-11-14
00812101031056DRI Tramadol Control KitARK DIAGNOSTICS INCDJG2024-11-14
00812101031063ARK™ Hydrocodone AssayARK DIAGNOSTICS INCDJG2024-10-16
00812101031070ARK™ Hydrocodone AssayARK DIAGNOSTICS INCDJG2024-10-16
00812101031087ARK™ Hydrocodone AssayARK DIAGNOSTICS INCDJG2024-10-16
00812101031094ARK™ Hydrocodone CalibratorARK DIAGNOSTICS INCDJG2024-10-16
00812101031100ARK™ Hydrocodone Calibrator NegativeARK DIAGNOSTICS INCDJG2024-10-16
00812101031117ARK™ Hydrocodone Calibrator CutoffARK DIAGNOSTICS INCDJG2024-10-16
00812101031124ARK™ Hydrocodone ControlARK DIAGNOSTICS INCDJG2024-10-16
10810124273153SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DJG2024-09-17