FDA.reportPublic FDA data

FIRST SIGN®

Primary DI
00817763020455
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCDIP1324
Catalog number
FSCDIP1324
Device description
DOA 2 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived BZO/OPI
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
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763020455PrimaryGS10
00817763021124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763020455008177630204558177630204550817763020455
00817763021124008177630211248177630211240817763021124

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
10810173655993HealgenHealgen Scientific Limited Liability CompanyJXM2026-03-11
10810173655597HealgenHealgen Scientific Limited Liability CompanyJXM2026-02-04
10810173655658HealgenHealgen Scientific Limited Liability CompanyJXM2026-02-04
00810173655101HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-31
10810173655603HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-30
10810173655641HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-30
00810173654821HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-08
00810173654838HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-08
00850054026989QMedix™Diagnostic Automation, Inc.JXM2025-12-23
00850054026996QMedix™Diagnostic Automation, Inc.JXM2025-12-23
10810173654002HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
10810173654149HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
10810173654644HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
00850013035830Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCJXM2025-12-04
0081703802225210 Panel Drug Test CupUCP BIOSCIENCES, INC.JXM2025-03-24
10815845024305SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.JXM2024-12-17
00841824105409N/AW.H.P.M. INC.JXM2024-06-14
10810124273023SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)ALERE SAN DIEGO, INC.JXM2023-12-15
10810124273283SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300)ALERE SAN DIEGO, INC.JXM2023-12-15
10810124273726CERTUM BZO One Step Benzodiazepines Test StripALERE SAN DIEGO, INC.JXM2023-12-15
00817763022367First SignHEMOSURE INC.JXM2023-05-18
04015630999347ONLINE DAT Benzodiazepines IIRoche Diagnostics GmbHJXM2023-05-11
07613336121054ONLINE DAT Benzodiazepines IIRoche Diagnostics GmbHJXM2023-05-11
00850041101750Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
00850041101781Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
00850041101798Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
10817405022936iCup™Instant Technologies, Inc.JXM2023-02-09
30817405022282iScreen™Instant Technologies, Inc.JXM2023-02-07
30817405022565iCassette™Instant Technologies, Inc.JXM2023-02-07
B77830573OD0Origin Instant Dip Drug TestORIGIN DIAGNOSTICS LLCJXM2022-12-07