FDA.report

FIRST SIGN®

Primary DI
00817763020165
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
D0115TC-02
Catalog number
D0115TC-02
Device description
DOA 15 in 1 Test Controls Set, 1 Positive & 1 Negative Control (20mL each); First Sign for Hemosure AMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR/MTD/OPI/OXY/PCP/TCA/THC
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DIFDrug Mixture Control Materials

Product Code Classifications

CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817763020165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763020165008177630201658177630201650817763020165

GMDN Terms

TermDefinition
Multiple drugs of abuse IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
806777541
Device count
1
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 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
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
00817763022121First Sign®FSCDIPMT-252018-05-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810042684416DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684423DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684430DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684447DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684355DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-19
00810042684362CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-17
00810042683822DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-02-20
00810042684331DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684348DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684324CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2024-11-21
00810042684263DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684270DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684287DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684294DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684300DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684317DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684249DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684256DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684232iScreenBIOCHEMICAL DIAGNOSTICS INCDIF2024-07-22
00810042683976DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683983DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683990DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684003DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684010DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684027DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684034DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684041DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684058DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684065DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684072DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12