FDA.reportPublic FDA data

National Test Systems

Primary DI
20817038021747
Brand
National Test Systems
Company
UCP BIOSCIENCES, INC.
Model
UCC-12-1M
Catalog number
UCC-12-1M
Device description
National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
Published
2017-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DISEnzyme Immunoassay, Barbiturate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151213000UCP Drug Test Mini CupsUcp Biosciences, Inc.2015-08-21DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817038021747PackageGS18In Commercial Distribution
10817038021740PrimaryGS10
00817038021743Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081703802174720817038021747
1081703802174010817038021740
00817038021743008170380217438170380217430817038021743

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
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDIS2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDIS2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2020-05-29
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDIS2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2019-02-12
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-12-05
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-07-05
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-06-20
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncDIS2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncDIS2018-05-21
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDIS2018-03-23
10694644500377RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDIS2018-03-14