FDA.report

FIRST SIGN®

Primary DI
00817763021704
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCDIP134
Catalog number
FSCDIP134
Device description
DOA 3 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived COC/OPI/THC
Published
2016-12-28
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

Related Records

Product Codes

CodeName
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications

CodeDeviceSpecialtyClass
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817763021704PrimaryGS10
00817763021728Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763021704008177630217048177630217040817763021704
00817763021728008177630217288177630217280817763021728

GMDN Terms

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

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
10810173655931HealgenHealgen Scientific Limited Liability CompanyLFG2026-03-11
10810173655955HealgenHealgen Scientific Limited Liability CompanyLFG2026-03-11
10810173655047HealgenHealgen Scientific Limited Liability CompanyLFG2026-02-04
10810173655689HealgenHealgen Scientific Limited Liability CompanyLFG2026-02-04
10810173655610HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655672Healgen Healgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655696HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655702HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
10810173655719HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-30
00810173654937HealgenHealgen Scientific Limited Liability CompanyLFG2026-01-08
10810173654521Healgen Healgen Scientific Limited Liability CompanyLFG2025-12-19
10810173654545HealgenHealgen Scientific Limited Liability CompanyLFG2025-12-19
10810173654651HealgenHealgen Scientific Limited Liability CompanyLFG2025-12-19
10815845023797SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LFG2024-12-17
10810124273085SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)ALERE SAN DIEGO, INC.LFG2023-12-15
00690286000780PROFILE-II ER®MEDTOX DIAGNOSTICS, INC.LFG2023-06-01
30817405022442iScreen™Instant Technologies, Inc.LFG2023-02-07
00869419000243Express ResultsTM Quest DiagnosticsLFG2022-03-28
20612479255306McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
20612479255337McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
20612479258444McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
10816862021780PreviewWONDFO USA CO., LTD.LFG2019-12-22
20817038021631UCP Home Drug Screening Test CupsUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021730UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021778UCP Drug Test Mini Cups UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021815u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2017-01-20
20817038021860u-Cup Drug Test ScreenUCP BIOSCIENCES, INC.LFG2017-01-20
20817038021891UCP Compact Drug Test Cups UCP BIOSCIENCES, INC.LFG2017-01-20
00895330002790Healgen (Private Label) - 3124CONFIRM BIOSCIENCES, INC.LFG2016-11-15
20817038021136u-Cup Drug Test Screen UCP BIOSCIENCES, INC.LFG2016-10-24