FDA.reportPublic FDA data

ImmuTest Drugs of Abuse Screen Card

Primary DI
00816565020007
Brand
ImmuTest Drugs of Abuse Screen Card
Company
AMEDITECH INC.
Model
IMD-AMP
Catalog number
IMD-AMP
Device description
Amphetamine single drug dipcard
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113046000AMEDITECH IMMUTEST MILTI-DRUG SCREENAmeditech, Inc.2011-11-10DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816565020007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816565020007008165650200078165650200070816565020007

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-858-535-1968xxx@xx.xx

Regulatory Flags#

DUNS number
010551716
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816565020366KNOWme™88433884332023-05-01
00816565020373KNOWme™88453884532023-05-01
00816565020380KNOWme™88431884312023-05-01
00816565021530eCUP + Drug Screening Device94615946152020-03-17
00816565021547eREADER+ Drug Screening Instrument 551612020-03-05
00816555020390ToxCup Drug Screen CupHT23HT232018-10-08
00816565020014ImmuTest Drugs of Abuse Screen CardIMD-BARIMD-BAR2016-09-01
00816565020021ImmuTest Drugs of Abuse Screen CardIMD-BZOIMD-BZO2016-09-01
00816565020038ImmuTest Drugs of Abuse Screen CardIMD-COCIMD-COC2016-09-01
00816565020045ImmuTest Drugs of Abuse Screen CardIMD-METIMD-MET2016-09-01
00816565020052ImmuTest Drugs of Abuse Screen CardIMD-OPI300IMD-OPI3002016-09-01
00816565020069ImmuTest Drugs of Abuse Screen CardIMD-THCIMD-THC2016-09-01
00816565020076ImmuTest Drugs of Abuse Screen CardIMD-12MO3IMD-12MO32016-09-01
00816565020083ImmuTest Drugs of Abuse Screen CardIMD-8MTIMD-8MT2016-09-01
00816565020090ImmuTest Drugs of Abuse Screen CardIMD-5BO300IMD-5BO3002016-09-01
00816565020106ImmuTest Drugs of Abuse Screen CardIMDA-3MIMDA-3M2016-09-01
00816565020113ImmuTest Drugs of Abuse Screen CardIMDA-5MIMDA-5M2016-09-01
00816565020120ImmuTest Drugs of Abuse CupIMC-3PIMC-3P2016-09-01
00816565020137ImmuTest Drugs of Abuse CupIMC-5BO3IMC-5BO32016-09-01
00816565020144ImmuTest Drugs of Abuse CupIMC-5MIMC-5M2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDKZ2023-04-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2021-06-24
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDKZ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2019-03-11
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-12-05
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-10-29
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-06-20
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23