FDA.reportPublic FDA data

ProScreen

Primary DI
00858998006296
Brand
ProScreen
Company
Instant Tech Subsidiary Acquisition
Model
PSD-6BUPO3
Catalog number
PSD-6BUPO3
Device description
Drugs of Abuse Test Card, BZO/BUP/COC/MTD/OPI300/OXY
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113046000AMEDITECH IMMUTEST MILTI-DRUG SCREENAmeditech, Inc.2011-11-10DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858998006296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858998006296008589980062968589980062960858998006296

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
1-888-669-4337xxx@xx.xx

Regulatory Flags#

DUNS number
080317182
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
00858998006012U-ScreenUSSCup-10MUSSCup-10M2016-10-26
00858998006029U-ScreenUSSCup-10MMO300USSCup-10MMO300UScreen with 10 Panel Drug Screen f2016-10-26
00858998006036U-ScreenUSSCup-5MUSSCup-5M2016-10-26
00858998006050U-ScreenUSSCup-7BO CLIAUSSCup-7BO CLIA2016-10-26
00858998006067U-ScreenUSSCupA-10MUSSCupA-10M2016-10-26
00858998006081U-ScreenUSSCupA-10MOB-300CLIAUSSCupA-10MOB-300CLIA2016-10-26
00858998006098U-ScreenUSSCupA-12USSCupA-122016-10-26
00858998006111U-ScreenUSSCupA-12BUP300CLIAUSSCupA-12BUP300CLIA2016-10-26
00858998006128U-ScreenUSSCupA-12CLIAUSSCupA-12CLIA2016-10-26
00858998006135U-ScreenUSSCupA-12NTCLIAUSSCupA-12NTCLIA2016-10-26
00858998006142U-ScreenUSSCupA-5MUSSCupA-5M2016-10-26
00858998006180U-ScreenUSSCupA-7MOBCLIAUSSCupA-7MOBCLIA2016-10-26
00858998006197U-ScreenUSSDip-6MBUSSDip-6MB2016-10-26
00858998006203ProScreenPSD-10MOBPSD-10MOB2016-09-19
00858998006234ProScreenPSD-10MOXPSD-10MOX2016-09-19
00858998006302ProScreenPSDA-5MPSDA-5M2016-09-19
00858998006326ProScreenPSDA-6CM5PSDA-6CM52016-09-22
00858998006333ProScreenPSDA-6MPPSDA-6MP2016-09-19
00858998006357ProScreenPSDA-8CM5PSDA-8CM52016-09-22
00858998006388ProScreenPSDA-8MBO300PSDA-8MBO3002016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJR2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07