FDA.reportPublic FDA data

Instant Test Cup

Primary DI
00816565020625
Brand
Instant Test Cup
Company
AMEDITECH INC.
Model
10-300
Catalog number
10-300
Device description
COC300, OPI300, AMP1000, MET1000, BZO300, 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
DJGEnzyme Immunoassay, Opiates
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
DJGEnzyme Immunoassay, OpiatesClinical 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
00816565020625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816565020625008165650206258165650206250816565020625

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
00311917077932WalgreensWALGREEN CO.NGG2026-10-14
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGG2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFV2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFT2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFV2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFY2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGG2026-10-13
06942598249376One Step® Fentanyl(FYL1) Urine Test PanelHangzhou AllTest Biotech Co., Ltd.DJG2026-10-12
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06942598249390One Step® Benzodiazepines (BZO300) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NFV2026-10-12
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGG2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGG2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21