FDA.reportPublic FDA data

MDMA Rapid Test Cassette

Primary DI
00853691007663
Brand
MDMA Rapid Test Cassette
Company
ACRO BIOTECH INC
Model
1
Device description
MDMA Rapid Test Cassette
Published
2017-06-28
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
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
00853691007663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853691007663008536910076638536910076630853691007663

GMDN Terms#

Term, Definition table
TermDefinition
Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of a specific methamphetamine in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079697380
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853691007205Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette1FHC-2022017-04-01
00853691007229hCG Enhanced Sensitivity Rapid Test Cassette 10 mIU/mL12017-07-06
00853691007670hCG Rapid Test Cassette 25 mIU/mL12017-07-03
00853691007687hCG Rapid Test Midstream 25 mIU/mL12017-07-03
00853691007694hCG Enhanced Sensitivity Rapid Test Midstream 10 mIU/mL12017-07-06
00853691007168THC Rapid Test Cassette12017-06-28
00853691007151OPI Rapid Test Cassette12017-06-28
00853691007113AMP Rapid Test Cassette12017-06-28
00853691007120BZO Rapid Test Cassette12017-06-28
00853691007137COC Rapid Test Cassette12017-06-28
00853691007595FOB Rapid Test Cassette12017-03-17
00853691007649MET Rapid Test Cassette12017-06-28
00853691007656PCP Rapid Test Cassette12017-06-28

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