FDA.reportPublic FDA data

Advin Multi-Drug Screen Test

Primary DI
B115ABCUP05451
Brand
Advin Multi-Drug Screen Test
Company
ADVIN BIOTECH, INC.
Model
ABCup-05-45
Catalog number
ABCup-05-45
Device description
AMP500/BZO300/COC150/MET500/OPI2000
Published
2019-09-25
Public version status
Update
Distribution status
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122809000Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech2013-06-17DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B115ABCUP05451PrimaryHIBCC0
B115ABCUP05450Unit of UseHIBCC0

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
(855)866-8382info@advinbio.com

Regulatory Flags#

DUNS number
006463333
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B115PABCUP12161Multi-Drug Screen Test P-ABCup-12-162026-05-01
B115ABCASS1CANAO25T1Advin COVID-19 Antigen Test @HomeABCASS(1)-CAN-AO-25T2025-12-29
B115VABCUP08661Multi-Drug Screen TestVABCup-08-662025-12-10
B115VABCUP08660Multi-Drug Screen TestVABCup-08-662025-12-10
B115VABCUP13721Multi-Drug Screen TestVABCup-13-722025-12-10
B115VABCUP15141Multi-Drug Screen TestVABCup-15-142025-12-10
B115VABCUP08651Multi-Drug Screen Test VABCup-08-652025-12-08
B115VABCUP08650Multi-Drug Screen Test VABCup-08-652025-12-08
B115ABCARD01MET5001Advin Multi-Drug Screen TestABCard-01-MET500ABCard-01-MET5002021-05-06
B115ABCARD05511Advin Multi-Drug Screen TestABCard-05-51ABCard-05-512020-08-26
B115ABCARD07461Advin Multi-Drug Screen TestABCard-07-46ABCard-07-462020-06-25
B115ABCARD09351Advin Multi-Drug Screen TestABCard-09-35ABCard-09-352020-06-25
B115ABCARD11371Advin Multi-Drug Screen Test 1ABCard-11-372021-12-17
B115ABCARD12711Advin Multi-Drug Screen TestABCard-12-71ABCard-12-712020-11-09
B115ABCARDA11391Advin Multi-Drug Screen Test with SVTABCardA-11-39ABCardA-11-392020-06-24
B115ABCARDC07431Advin Multi-Drug Screen Test with SVTABCardC-07-43ABCardC-07-432021-02-15
B115ABCARDC12441Advin Multi-Drug Screen Test with SVTABCardC-12-44ABCardC-12-442020-06-25
B115ABCARDC12711Advin Multi-Drug Screen Test with SVTABCardC-12-71ABCardC-12-712020-06-25
B115ABCUP05511Advin Multi-Drug Screen TestABCup-05-51ABCup-05-512020-08-26
B115ABCUP07461Advin Multi-Drug Screen TestABCup-07-46ABCup-07-462020-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28