FDA.reportPublic FDA data

FIRST SIGN®

Primary DI
00817763020813
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCDIPMA-25
Catalog number
FSCDIPMA-25
Device description
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived mAMP
Published
2016-10-07
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
DJCThin Layer Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763020813PrimaryGS10
00817763021520Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763020813008177630208138177630208130817763020813
00817763021520008177630215208177630215200817763021520

GMDN Terms#

Term, Definition table
TermDefinition
Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of a specific methamphetamine 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
00850013035991Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJC2025-12-15
10815845024220SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJC2024-12-17
10815845024404SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJC2024-12-17
10810124273597SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DJC2024-09-17
10810124273610SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DJC2024-09-17
10810124273689SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DJC2024-09-17
10840050517519Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DJC2024-08-28
10810124273757CERTUM mAMP One Step Methamphetamine Test StripALERE SAN DIEGO, INC.DJC2023-12-15
10810124273764CERTUM mAMP One Step Methamphetamine Test StripALERE SAN DIEGO, INC.DJC2023-12-15
16970429841632DTPMCo-Innovation Biotech Co., LtdDJC2023-12-08
00796918002440Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.DJC2022-11-07
20817038022119u-Card Drug Test ScreenUCP BIOSCIENCES, INC.DJC2022-06-16
00869419000212Express ResultsTM Quest DiagnosticsDJC2022-03-28
20817038022096AYDMED Rapid Multi-Drug Test Dip CardUCP BIOSCIENCES, INC.DJC2022-03-01
00816036028037STATSWAB3MICRO DISTRIBUTING, L.CDJC2021-11-09
B115ABCARD01MET5000Advin Multi-Drug Screen TestADVIN BIOTECH, INC.DJC2021-05-06
20817038022058u-CardTM Drug Test ScreenUCP BIOSCIENCES, INC.DJC2020-11-09
10817038022013u-Card TM Drug Test Screen 7 panel Test Card UCP BIOSCIENCES, INC.DJC2020-02-29
10817038022020AIDTEQ Rapid Multi-Drug Test Dip CardUCP BIOSCIENCES, INC.DJC2020-02-29
10850013035035Identify HealthMEDICAL DISTRIBUTION GROUP INCDJC2020-01-08
00858984006309NexScreen Drug Dip CardNEXSCREEN, LLCDJC2019-12-11
00858984006323NexScreen Drug Dip CardNEXSCREEN, LLCDJC2019-12-11
00722066000571Rapid ResponseBTNX IncDJC2019-10-16
00817405020713ProScreenInstant Technologies, Inc.DJC2019-10-14
M90107RD7065430QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJC2019-09-24
10833143000043iCup®Instant Technologies, Inc.DJC2019-08-19
00722066000564Rapid ResponseBTNX IncDJC2019-07-25
20850721007932Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJC2019-05-13
10850721007928Identify HealthMEDICAL DISTRIBUTION GROUP INCDJC2019-04-29
10850721007829Identify HealthMEDICAL DISTRIBUTION GROUP INCDJC2019-02-27