FDA.reportPublic FDA data

FIRST SIGN®

Primary DI
00817763020639
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCCUP-3464
Catalog number
FSCCUP-3464
Device description
DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/mAMP/MOR/PCP/THC
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
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763020639PrimaryGS10
00817763021308Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763020639008177630206398177630206390817763020639
00817763021308008177630213088177630213080817763021308

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
10810173655962HealgenHealgen Scientific Limited Liability CompanyLCM2026-03-11
10810173655566HealgenHealgen Scientific Limited Liability CompanyLCM2026-02-04
00810173654920HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
00810173655071HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173655085HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173654774HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
10810173654798HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
00812101031599ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031605ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031612ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031995ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
10810173654538Healgen Healgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654576HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654637HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
08500130357170Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035809Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035878Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035076Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLCM2025-09-11
10816862026785Prime ScreenWONDFO USA CO., LTD.LCM2025-07-03
10816862026358SAFElife™WONDFO USA CO., LTD.LCM2024-12-24
10815845023162SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LCM2024-12-17
00817763022510First Sign®HEMOSURE INC.LCM2024-10-16
00812203030780DrugSmart CupCHEMTRON BIOTECH INCLCM2024-07-29
10810124273245SureStepTM Urine Test Drug Screen Strip, Phencyclidine (PCP 25)ALERE SAN DIEGO, INC.LCM2023-12-15
00858886006827Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLCM2023-10-20
00817815021119CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.LCM2023-08-23
10690286000763PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.LCM2023-08-01
30817405023821iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405023883iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405021711iScreen™Instant Technologies, Inc.LCM2023-02-07