FDA.reportPublic FDA data

Speedy Tests

Primary DI
10866415000311
Brand
Speedy Tests
Company
SPEEDY SOLUTIONS LLC
Model
STDIPMA-25
Catalog number
STDIPMA-25
Device description
Speedy Tests DOA Single Test Dipcard, 25Pcs/BoxmAMP
Published
2017-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DJCThin Layer Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866415000311PrimaryGS10
00866415000314Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086641500031110866415000311
00866415000314008664150003148664150003140866415000314

GMDN Terms#

Term, Definition table
TermDefinition
Disopyramide therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug disopyramide in a clinical specimen.

Regulatory Flags#

DUNS number
080428145
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10866415000328Speedy TestsSTDIPOP-25STDIPOP-252017-03-09
10866415000335Speedy TestsSTDIP3104STDIP31042017-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDJC2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJC2021-05-28
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10722066005139Rapid ResponseBTNX IncDJC2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2020-05-29
10722066005108Rapid ResponseBTNX IncDJC2020-02-12
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJC2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-07-05
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-05-23
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDJC2018-02-13
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-04-06
10694644300656RDSAMERICAN BIO MEDICA CORPORATIONDJC2017-04-06
10694644300632RDSAMERICAN BIO MEDICA CORPORATIONDJC2016-12-14
10743816001386Status Stick™ 5/MET StickPRINCETON BIOMEDITECH CORPORATIONDJC2016-11-07
10763924001429accutest®JANT PHARMACAL CORPORATIONDJC2016-09-24
10763924007629accutest®JANT PHARMACAL CORPORATIONDJC2016-09-24
10763924009623accutest®JANT PHARMACAL CORPORATIONDJC2016-09-24
10763924012623accutest®JANT PHARMACAL CORPORATIONDJC2016-09-24