FDA.reportPublic FDA data

First Sign®

Primary DI
00817763022268
Brand
First Sign®
Company
HEMOSURE INC.
Model
FSCCUP-20104 W/AD7
Device description
DOA 10 in 1 Test Cup W/ AD, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MOR/MTD/OXY/THC/CR-SG-OX
Published
2018-07-23
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
DISEnzyme Immunoassay, Barbiturate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763022268PrimaryGS10
00817763022275Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763022268008177630222688177630222680817763022268
00817763022275008177630222758177630222750817763022275

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
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
00817763022121First Sign®FSCDIPMT-252018-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810173655726HealgenHealgen Scientific Limited Liability CompanyDIS2026-01-30
00810173654760HealgenHealgen Scientific Limited Liability CompanyDIS2026-01-08
10810173653951HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810173654057HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810173654675HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810124273849CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIS2024-12-17
10815845023155SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DIS2024-12-17
05055273216752Evidence MultiSTAT DOA Urine MultiPlexRANDOX LABORATORIES LIMITEDDIS2024-09-16
10817405024077iScreen™ Urine Test E-Z Split Key™ Drug Screen CupInstant Technologies, Inc.DIS2024-07-16
10810124273009SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)ALERE SAN DIEGO, INC.DIS2023-12-15
10810124273276SureStep™ Urine Test Drug Screen Cassette, Barbiturates (BAR 300)ALERE SAN DIEGO, INC.DIS2023-12-15
10810124273719CERTUM BAR One Step Barbiturates Test StripALERE SAN DIEGO, INC.DIS2023-12-15
16970429841342DTPMCo-Innovation Biotech Co., LtdDIS2023-12-08
00817815021089CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.DIS2023-08-23
00817815021324CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.DIS2023-08-23
10690286000770PROFILE®-IIAMEDTOX DIAGNOSTICS, INC.DIS2023-06-01
10817405022806iCup™Instant Technologies, Inc.DIS2023-02-06
10817405023049iCup™Instant Technologies, Inc.DIS2023-02-06
30817405021476iScreen™Instant Technologies, Inc.DIS2023-02-01
B298608040DrugCheckExpress Diagnostic Int'l, Inc.DIS2022-10-14
B298610700DrugCheckExpress Diagnostic Int'l, Inc.DIS2022-07-22
00811727017178Pointe Barbiturate Reagent SetPOINTE SCIENTIFIC, INC.DIS2020-09-25
00811727017185Pointe Barbiturate Reagent SetPOINTE SCIENTIFIC, INC.DIS2020-09-25
10690286000701EZ-SCREEN® CUPMEDTOX DIAGNOSTICS, INC.DIS2020-08-04
07613336121030ONLINE DAT Barbiturates PlusRoche Diagnostics GmbHDIS2020-03-05
00860113002021MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002038MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002045MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002052MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
B29830150C10DrugCheckExpress Diagnostic Int'l, Inc.DIS2019-12-31