FDA.reportPublic FDA data

Advin Multi-Drug Screen Test

Primary DI
B115ABCARD11370
Brand
Advin Multi-Drug Screen Test
Company
ADVIN BIOTECH, INC.
Model
1
Catalog number
ABCard-11-37
Device description
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25
Published
2021-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

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
B115ABCARD11371PrimaryHIBCC0
B115ABCARD11370Unit 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 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. It is not intended to be used 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
(855)866-8382info@advinbio.com

Regulatory Flags#

DUNS number
006463333
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810173656702AccurateHealgen Scientific Limited Liability CompanyLCM2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLCM2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLCM2019-02-13
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONLCM2018-02-13
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2017-10-12