FDA.reportPublic FDA data

AmediCheck Instant Test Cup

Primary DI
00816555020314
Brand
AmediCheck Instant Test Cup
Company
BRANAN MEDICAL CORPORATION
Model
C-C0501A-3A
Catalog number
C-C0501A-3A
Device description
THC, COC, OPI, AMP, PCP with Adulteration Screen for OX/SG/PH
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids
NFTTest, Amphetamine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063379000AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220Amedica Biotech, Inc.2006-12-11DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816555020314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816555020314008165550203148165550203140816555020314

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-468-3287info@brananmedical.com

Regulatory Flags#

DUNS number
184347305
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
00816555020031Monitect Drug Screen Cassette TestMC14MC142016-08-01
00816555020048Monitect Drug Screen Cassette TestMC15MC152016-08-01
00816555020055Monitect Drug Screen Cassette TestMC16MC162016-08-01
00816555020116Monitect Drug Screen Cassette TestMC22MC222016-08-01
00816555020161Monitect Drug Screen Cassette TestBC28BC282016-08-01
00816555020994Fastect II Drug Screen Dipstick TestMF14MF142016-08-01
00816555021007Fastect II Drug Screen Dipstick TestMF16MF162016-08-01
00816555021069Fastect II Drug Screen Dipstick TestMF22MF222016-08-01
00816555020000Monitect Drug Screen Cassette TestMC10MC102016-08-01
00816555020963Fastect II Drug Screen Dipstick TestMF10MF102016-08-01
00816555020017Monitect Drug Screen Cassette TestMC11MC112016-08-01
00816555020024Monitect Drug Screen Cassette TestMC13MC132016-08-01
00816555020062Monitect Drug Screen Cassette TestMC17MC172016-08-01
00816555020079Monitect Drug Screen Cassette TestMC18MC182016-08-01
00816555020086Monitect Drug Screen Cassette TestMC19MC192016-08-01
00816555020093Monitect Drug Screen Cassette TestMC20MC202016-08-01
00816555020109Monitect Drug Screen Cassette TestMC21MC212016-08-01
00816555020123Monitect Drug Screen Cassette TestMC23MC232016-08-01
00816555020130Monitect Drug Screen Cassette TestBC10BC102016-08-01
00816555020154Monitect Drug Screen Cassette TestBC17SBC17S2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917077932WalgreensWALGREEN CO.NFY2026-10-14
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
00311917077932WalgreensWALGREEN CO.NFW2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.LCM2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFW2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.LCM2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFY2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFY2026-10-13
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFT2026-10-13
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
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
10722066005511Rapid ResponseBTNX IncNGL2026-10-09
10722066005511Rapid ResponseBTNX IncNFY2026-10-09
10722066005511Rapid ResponseBTNX IncNFW2026-10-09
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
06936983114011Alltest THC50 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFW2026-04-21
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
06936983114066Alltest COC150 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFY2026-04-21
06936983114103Alltest MOP300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21