UCP Home Drug Screening Test Cups

Primary DI
20817038020580
Brand
UCP Home Drug Screening Test Cups
Company
UCP BIOSCIENCES, INC.
Model
U-CUP-7124-RCN
Catalog number
U-CUP-7124-RCN
Device description
12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/PPX/BUP
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JXNEnzyme Immunoassay, Propoxyphene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130463000UCP HOME DRUG SCREENING TEST; CARDS, CUPSUcp Biosciences, Inc.2013-05-15DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817038020580PackageGS18In Commercial Distribution
10817038020583PrimaryGS10
00817038020586Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081703802058020817038020580
1081703802058310817038020583
00817038020586008170380205868170380205860817038020586

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

Regulatory Flags#

DUNS number
163610020
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817038021955u-Card TM Drug Test Screen 3 panel Test CardU-DOA-234LU-DOA-234L2018-11-01
10817038021962u-Cup TM Drug Test Screen 8 Panel Drug Test CupU-CUP-384U-CUP-3842018-11-01
10817038021979UCP Compact Drug Test CupsUCC-A1001M-A3AUCC-A1001M-A3A2018-11-26
10817038022044U-UCPTM Drug Test Screen 12 Panel Drug Test CupU-DUD-20124U-DUD-201242020-10-23
10817038022051u-CardTM Drug Test ScreenU-DOA-654U-DOA-6542020-11-09
10817038022068U-UCPTM Drug Test Screen 12 Panel Drug Test CupU-DUD-20124U-DUD-201242021-05-24
108170380220756 Panel Drug Test CupU-CUP-2064-3ADU-CUP-2064-3AD2021-10-13
10817038022099AYDMED Rapid Multi-Drug Test Dip CardDOA-3174-061DOA-3174-0612022-03-01
10817038022112u-Card Drug Test ScreenU-MET-114LU-MET-114L2022-06-16
10817038022129OEM 81-13 Drug Test U-DOA-134U-DOA-1342023-04-07
10817038022136OEM 81-13 Drug Test U-DOA-654U-DOA-6542023-04-07
10817038022143OEM 81-13 Drug Test U-DOA-254U-DOA-2542023-04-07
10817038022150OEM 81-13 Drug Test U-DOA-264U-DOA-2642023-04-07
10817038022167OEM 81-13 Drug Test U-DOA-244U-DOA-2442023-04-07
10817038022211u-CardTM Drug Test Screen 12 Panel Test Card U-DOA-20124U-DOA-201242024-01-04
10817038022228OEM 81-13 Drug Test 5 Panel Test CupU-CUP-654U-CUP-6542024-04-09
10817038022235OEM 81-13 Drug Test 6 Panel Test CupU-CUP-264U-CUP-2642024-04-09
10817038022242inSight 12 Panel Drug Test CupIS-12P-CWIS-12P-CW2024-05-16
1081703802225910 Panel Drug Test CupU-CUP-13104U-CUP-131042025-03-24
10817038022266u-CupTM Drug Test ScreenU-DUD-20124U-DUD-201242025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290006418326CHROMOSTREAKSAVYON DIAGNOSTICS LTDJXN2026-05-27
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONJXN2021-06-24
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2020-05-29
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONJXN2019-03-11
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2019-02-12
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONJXN2018-10-29
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONJXN2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2018-03-30
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONJXN2018-02-16
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-10-12
10694644400677INCUPAMERICAN BIO MEDICA CORPORATIONJXN2017-10-10
10694644500254RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-08-02
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-06-29
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONJXN2017-06-08
10694644500247RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-05-31
10694644400660INCUPAMERICAN BIO MEDICA CORPORATIONJXN2017-05-05
10694644500230RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-04-25
10694644400653INCUPAMERICAN BIO MEDICA CORPORATIONJXN2017-03-21
10694644500216RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-03-13
10694644500223RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-03-13
10694644500193RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-01-12
10694644500209RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2017-01-12
10694644400646INCUPAMERICAN BIO MEDICA CORPORATIONJXN2016-12-08
10694644500186RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2016-11-29
10694644400639INCUPAMERICAN BIO MEDICA CORPORATIONJXN2016-11-15
10694644500179RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONJXN2016-11-02