FDA.reportPublic FDA data

INSTANT-VIEW MDMA (XTC) Urine Dip Cassette Test

Primary DI
10796918000221
Brand
INSTANT-VIEW MDMA (XTC) Urine Dip Cassette Test
Company
ALFA SCIENTIFIC DESIGNS, INC.
Model
03-2952QW
Device description
INSTANT-VIEW MDMA (XTC) Urine Dip Cassette Test
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10796918000221PrimaryGS10
00796918000224Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079691800022110796918000221
00796918000224007969180002247969180002240796918000224

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group 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 the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] 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. It is not intended for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176391167
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00796918002440Multi-Drug of Abuse Urine Cup Test03-46802022-11-07
00796918002433Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THC03-44392021-09-24
00796918002426INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR30003-39482021-07-29
00796918002419INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, T03-3803QW2021-07-12
00796918002204INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR30003-39422021-04-21
00796918002198INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR3003-39452020-09-14
20796918001904INSTANT-VIEW FOB Test - complete kit, 25 test05-7601-252019-07-01
30796918001901INSTANT-VIEW FOB Test - complete kit, 50 test05-7601-502019-07-01
10796918002096INSTANT-VIEW FOB Test05-7602-502019-05-01
10796918001778INSTANT-VIEW FOB Test05-76022016-09-23
10796918001785INSTANT-VIEW FOB Test05-7602-22016-09-23
10796918001907INSTANT-VIEW FOB Test05-76022017-04-10
10796918001914Instant-view plus Immunochemical Fecal Occult Blood Test05-76322018-08-28
10796918001921Instant-view plus Immunochemical Fecal Occult Blood Test05-7632OT2018-08-28
10796918002188INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THC03-35512019-09-23
10796918002171INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET, MOR300, THC03-34622019-06-12
10796918002157INSTANT-VIEW LH Midstream Cassette Test, 6 tests02-2540-62019-06-03
10796918002164INSTANT-VIEW FSH Midstream Cassette Test02-25602019-06-03
10796918002140 Instant-View HCG Midstream Cassette, 2t02-2480-22019-05-30
10796918002119INSTANT-VIEW Marijuana (THC) Urine Dip Cassette Test03-3072OT-52019-05-03

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Primary DI, Brand, Company table
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10815845024404SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DJC2024-12-17
10810124273597SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DJC2024-09-17
10810124273610SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DJC2024-09-17
10810124273689SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DJC2024-09-17
10840050517519Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DJC2024-08-28
10810124273757CERTUM mAMP One Step Methamphetamine Test StripALERE SAN DIEGO, INC.DJC2023-12-15
10810124273764CERTUM mAMP One Step Methamphetamine Test StripALERE SAN DIEGO, INC.DJC2023-12-15
16970429841632DTPMCo-Innovation Biotech Co., LtdDJC2023-12-08
00796918002440Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.DJC2022-11-07
20817038022119u-Card Drug Test ScreenUCP BIOSCIENCES, INC.DJC2022-06-16
00869419000212Express ResultsTM Quest DiagnosticsDJC2022-03-28
20817038022096AYDMED Rapid Multi-Drug Test Dip CardUCP BIOSCIENCES, INC.DJC2022-03-01
00816036028037STATSWAB3MICRO DISTRIBUTING, L.CDJC2021-11-09
B115ABCARD01MET5000Advin Multi-Drug Screen TestADVIN BIOTECH, INC.DJC2021-05-06
20817038022058u-CardTM Drug Test ScreenUCP BIOSCIENCES, INC.DJC2020-11-09
10817038022013u-Card TM Drug Test Screen 7 panel Test Card UCP BIOSCIENCES, INC.DJC2020-02-29
10817038022020AIDTEQ Rapid Multi-Drug Test Dip CardUCP BIOSCIENCES, INC.DJC2020-02-29
10850013035035Identify HealthMEDICAL DISTRIBUTION GROUP INCDJC2020-01-08
00858984006309NexScreen Drug Dip CardNEXSCREEN, LLCDJC2019-12-11
00858984006323NexScreen Drug Dip CardNEXSCREEN, LLCDJC2019-12-11
00722066000571Rapid ResponseBTNX IncDJC2019-10-16
00817405020713ProScreenInstant Technologies, Inc.DJC2019-10-14
M90107RD7065430QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJC2019-09-24
10833143000043iCup®Instant Technologies, Inc.DJC2019-08-19
00722066000564Rapid ResponseBTNX IncDJC2019-07-25
20850721007932Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJC2019-05-13
10850721007928Identify HealthMEDICAL DISTRIBUTION GROUP INCDJC2019-04-29
10850721007829Identify HealthMEDICAL DISTRIBUTION GROUP INCDJC2019-02-27