FDA.reportPublic FDA data

mCup®

Primary DI
10867802000266
Brand
mCup®
Company
ESCREEN, INC.
Model
MCP5A-001
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10867802000266PrimaryGS10
00867802000269Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086780200026610867802000266
00867802000269008678020002698678020002690867802000269

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014079359
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10867802000228mCup®MCP7A-001 2016-09-24
10867802000235mCup®MCP9A-0012016-09-24
10867802000242mCup®MCP10A-0012016-09-24
10867802000259mCup®MCP11A-0012016-09-24
10867802000273xCupTMDUE-1117X-071-01DUE-1117X-071-012016-09-24
10867802000280eScreen eCupeCup2012016-09-16
10860429001012eCUP™E&I eCUP™2062020-04-24
10867802000211mCup®MCP5-0012016-09-24
00860429001022eREADER™E&I V3 - Serviced20900000032020-04-24
00860429001039eREADER™E&I V4 - Serviced20900000042020-04-24
00860429001046eREADER™E&I V3 - New20700000032020-04-24
00860429001053eREADER™E&I V4 - New20700000042020-04-24
00860429001008eScreen eReaderV4207 / 2092018-04-12
00867802000207eScreen eReaderV3207 / 2092016-08-26
00867802000290xReader SystemBS-0610S3012016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDIO2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLAF2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03