FDA.reportPublic FDA data

Eleven Panel PreScreen Plus Dip Card (CLIA Waived)

Primary DI
00850557007065
Brand
Eleven Panel PreScreen Plus Dip Card (CLIA Waived)
Company
MERGERS MARKETING, INC.
Model
PS-DOA-1114
Device description
Eleven Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP BAR BZO COC MDMA MET OPI MTD PPX PCP THC
Published
2016-07-26
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
LAJGas Chromatography, Propoxyphene
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

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
LAJGas Chromatography, PropoxypheneClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850557007072PackageGS125In Commercial Distribution
10850557007079PackageGS120In Commercial Distribution
00850557007065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850557007072008505570070728505570070720850557007072
1085055700707910850557007079
00850557007065008505570070658505570070650850557007065

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

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10850013035004Identify Diagnostics USAMEDICAL DISTRIBUTION GROUP INCDJR2026-10-30
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00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
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00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
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