FDA.reportPublic FDA data

Twelve Panel PreScreen Plus Dip Card (CLIA Waived)

Primary DI
00850557007249
Brand
Twelve Panel PreScreen Plus Dip Card (CLIA Waived)
Company
MERGERS MARKETING, INC.
Model
PS-DOA-7125
Device description
Twelve Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo:AMP BAR BZO COC MDMA MET MOR MTD OXY PCP TCA THC
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850557007256PackageGS125In Commercial Distribution
10850557007253PackageGS120In Commercial Distribution
00850557007249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850557007256008505570072568505570072560850557007256
1085055700725310850557007253
00850557007249008505570072498505570072490850557007249

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065602744
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850557007089Twelve Panel PreScreen Plus Dip Card (CLIA Waived)PS-DOA-11242016-07-26
00850557007126Five Panel PreScreen Plus Dip Card (CLIA Waived)PS-DOA-15542016-07-26
00850557007225Ten Panel PreScreen Plus Dip Card (CLIA Waived)PS-DOA-31042016-07-26
00850557007263Ten Panel PreScreen Plus Dip Card (CLIA Waived)PS-DOA-41042016-07-26
00850557007287Six Panel PreScreen Plus Dip Card (CLIA Waived)PS-DOA-5642016-07-26
00850557007409Single Panel Pre Screen Plus Dip CardPS-THC-1142016-07-26
00850557007485Six Panel PreScreen Plus Cup With Adulterants (CLIA Waived)PSC-DOA-264AD2016-07-25
00850557007829Five Panel Clear Scan Drug Test CupCSC-2542016-07-25
00850557007843Five Panel Clear Scan Drug Test Cup With AdulterantsCSC-254AD2016-07-25
00850557007867Five Panel Clear Scan Drug Test CupCSC-6542016-07-25
00850557007980Thirteen Panel Clear Scan Drug Test CupCSC-21352016-07-25
00851000007007Thirteen Panel Clear Scan Drug Test Cup With AdulterantsCSC-2135 AD2016-07-25
00851000007021Twelve Panel Clear Scan Drug Test Cup With AdulterantsCSC-6125AD2016-08-31
00851000007045Five Panel PreScreen Plus Cup (CLIA Waived) With AlcoholPSC-DOA-254A2016-08-31
00851000007069Ten Panel PreScreen Plus Cup (CLIA Waived) With AlcoholPSC-DOA-4104A2016-08-31
00851000007083Single Panel Pre Screen Plus Dip CardPS-ETG2016-08-31
00851000007106Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived)PSC-DOA-7125AD2016-09-26
00851000007137Five Panel PreScreen Plus Cup (CLIA Waived)PSC-DOA-1542016-09-27
00851000007151Six Panel PreScreen Plus Dip Card (CLIA Waived)PS-DOA-1642016-11-08
00851000007168Five Panel PreScreen Plus Mini Cup (CLIA Waived)PSC-DOA-254M2016-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28