FDA.report

FIRST SIGN®

Primary DI
00817763020394
Brand
FIRST SIGN®
Company
HEMOSURE INC.
Model
FSCDIP19124
Catalog number
FSCDIP19124
Device description
DOA 12 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BARB/BUP/BZO/COC/mAMP/MOR/MTD/OPI/OXY/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

Related Records

Product Codes

CodeName
DJREnzyme Immunoassay, Methadone

Product Code Classifications

CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817763020394PrimaryGS10
00817763020950Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763020394008177630203948177630203940817763020394
00817763020950008177630209508177630209500817763020950

GMDN Terms

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

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

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00817763022183First Sign®FSCDIP50542018-05-14
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00817763022060First Sign®FSCDIPED-252018-05-09
00817763022084First Sign®FSCDIPMD-252018-05-09
00817763022107First Sign®FSCDIPMO-252018-05-09

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