FDA.reportPublic FDA data

Accutest CLEAR Opiates Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit

Primary DI
10763924317919
Brand
Accutest CLEAR Opiates Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
Company
JANT PHARMACAL CORPORATION
Model
DS317
Device description
Accutest CLEAR Opiates Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.Clinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924317919PrimaryGS10
00763924317912Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076392431791910763924317919
00763924317912007639243179127639243179120763924317912

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of opiate and/or opiate metabolites in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
797393659
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

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10763924320919Accutest CLEAR MDMA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3202016-09-20
10763924095213Accutest Breath Alcohol DetectorDS95AC2202016-09-24
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10763924210142AccutestUA702A2016-09-24
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10763924850508Accustrip Urine Reagent Strip ReaderUA8502016-09-24
10763924870100Accustrip 10-Parameter Urine Reagent Strip UA870007639248701032016-09-24
10763924319913Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3192016-09-20
20763924897104Accustrip URS Strips + ReaderUA8972016-09-24
10763924309914Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/KitDS3092016-09-20
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