FDA.reportPublic FDA data

Instant Test Cup

Primary DI
00816565020618
Brand
Instant Test Cup
Company
AMEDITECH INC.
Model
10-200
Catalog number
10-200
Device description
COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 with Adulteration OX/SG/pH Drugs of Abuse Test Cup (CLIA WAIVED)
Published
2017-03-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
LCMEnzyme Immunoassay, Phencyclidine
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082898000AMEDICA DRUG SCREEN TEST CUPAmedica Biotech, Inc.2008-12-19NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816565020618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816565020618008165650206188165650206180816565020618

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 one or multiple drugs of abuse 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

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
00816565020007ImmuTest Drugs of Abuse Screen CardIMD-AMPIMD-AMP2016-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGL2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFY2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFT2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGG2026-07-09
00841824104167ECOIIW.H.P.M. INC.DIS2026-07-07
00841824104167ECOIIW.H.P.M. INC.LCM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJR2026-07-07
00810174471229Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFT2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.LCM2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGG2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFV2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFT2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIS2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLFG2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03