FDA.reportPublic FDA data

Preknow Multi-Drug (AMP/BZO/COC/OPI/THC) Screen Test (5 Dipcards)

Primary DI
00857275007131
Brand
Preknow Multi-Drug (AMP/BZO/COC/OPI/THC) Screen Test (5 Dipcards)
Company
IDUN SOLUTIONS LLC
Model
IDOA-755-5P
Device description
5 tests kit; 5-Panel Dip Cards; AMP/BZO/COC/OPI/THC
Published
2017-05-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DKZEnzyme Immunoassay, Amphetamine
DNKThin Layer Chromatography, Morphine
JXMEnzyme Immunoassay, Benzodiazepine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
DNKThin Layer Chromatography, MorphineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153050000Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.2016-04-26DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857275007032PackageGS15In Commercial Distribution
00857275007131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857275007032008572750070328572750070320857275007032
00857275007131008572750071318572750071310857275007131

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid 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 cannabinoids 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080651010
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857275007544PreKnow211000154105082018-08-02
00857275007100PreKnow Pregnancy Test (25 hCG Strips)ID1-S-25P2017-05-16
00857275007735PreKnow211000154103082018-10-15
00857275007162PreChek Multi-Drug Test CupIDOA-7225RC-5P2018-06-20
00857275007520PreChek215120500103082018-08-02
00857275007575PreChek21512050010308-A2018-08-02
90857275007837Wholepower415111040010342019-09-02
00857275007797N/M125113150000342019-08-26
00857275007285PreChek Multi-Drug Test Square CupIDOA-7325SC-25P2018-06-20
00857275007179PreKnowIDOA-7562018-05-22
00857275007186PreKnowIDOA-31052018-05-23
00857275007513PreKnow215050400103082018-08-02
00857275007537PreKnow21115061010308-B2018-08-02
90857275007813N/M125111050000342019-08-26
00857275007124Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)IDTH-115-15P2017-05-16
00857275007506PreKnow211150610103082018-08-02
00857275007568PreKnow21505040010308-C2018-08-02
00857275007551PreKnow211030154105082018-08-02
00857275007490PreKnow211140616103082018-08-02
00857275007070PreKnowIDOA-7562018-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DKZ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07