FDA.reportPublic FDA data

FIRST SIGN®

Primary DI
00817763021315
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCDIP12104
Catalog number
FSCDIP12104
Device description
DOA 10 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY/THC
Published
2016-10-19
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
LAFGas Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAFGas Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763021315PrimaryGS10
00817763021322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763021315008177630213158177630213150817763021315
00817763021322008177630213228177630213220817763021322

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
10810173655948HealgenHealgen Scientific Limited Liability CompanyLAF2026-03-11
10810173654804HealgenHealgen Scientific Limited Liability CompanyLAF2026-01-08
10810173654552HealgenHealgen Scientific Limited Liability CompanyLAF2025-12-19
00812203030810DrugSmartCHEMTRON BIOTECH INCLAF2025-09-26
00841824105645N/AW.H.P.M. INC.LAF2025-06-13
00812203030858GenericCHEMTRON BIOTECH INCLAF2025-02-24
00812203030797GenericCHEMTRON BIOTECH INCLAF2024-07-29
00812203030766Premier BiotechCHEMTRON BIOTECH INCLAF2024-05-28
00812203030728GenericCHEMTRON BIOTECH INCLAF2024-04-09
00812203030735Premier BiotechCHEMTRON BIOTECH INCLAF2024-04-08
00812203030674GenericCHEMTRON BIOTECH INCLAF2024-02-05
00812203030667GenericCHEMTRON BIOTECH INCLAF2024-02-01
10810124273047SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)ALERE SAN DIEGO, INC.LAF2023-12-15
10810124273054SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500ALERE SAN DIEGO, INC.LAF2023-12-15
10810124273214SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)ALERE SAN DIEGO, INC.LAF2023-12-15
10810124273313SureStepTM Urine Drug Test CassetteALERE SAN DIEGO, INC.LAF2023-12-15
30817405021483iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021506iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021520iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021537iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021605iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021612iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021674iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021728iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021735iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021902iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021926iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021933iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021940iScreen™Instant Technologies, Inc.LAF2023-02-07
30817405021957iScreen™Instant Technologies, Inc.LAF2023-02-07