FDA.reportPublic FDA data

Platinum+

Primary DI
00850011007310
Brand
Platinum+
Company
MERCEDES MEDICAL, LLC
Model
MER HCDOAY6125
Catalog number
MER HCDOAY6125
Device description
Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
Published
2018-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011007327PackageGS125In Commercial Distribution
00850011007334PackageGS14In Commercial Distribution
00850011007310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011007327008500110073278500110073270850011007327
00850011007334008500110073348500110073340850011007334
00850011007310008500110073108500110073100850011007310

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test 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
Special Storage Condition, Specify00Keep out of direct sunlight and store between 35.6 - 86 deg F

Contacts#

Phone, Email table
PhoneEmail
800-331-2716mmcwhorter@mercedesmedical.com

Regulatory Flags#

DUNS number
834472680
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011007228BluWingMER 1921MER 19212017-07-01
00850011007235BluWingMER 1923MER 19232017-07-01
00850011007242BluWingMER 1925MER 19252017-07-01
00850011007143Tanner Scientific®TNR 10SGTNR 10SG2016-08-15
00850011007280BluRapidsTNR CDOA6125MTNR CDOA6125M2017-08-09
00850011007174Tanner Scientific®TNR HCGCOMBOTNR HCGCOMBO2016-08-22
00860008185136BluTouchTNR 700XLTNR 700XL2023-05-15
00860008185112BluTouchTNR 700LTNR 700L2023-05-15
10860008185133BluTouchTNR 700XLTNR 700XL2023-05-15
00860008185105BluTouchTNR 700STNR 700S2022-12-28
00860008185129BluTouchTNR 700MTNR 700M2022-12-28
00850011007129Tanner Scientific®TNR DOA12ATNR DOA12A2016-08-15
00850011007136Tanner Scientific®TNR DOA13ATNR DOA13A2016-08-15
00850011007570Platinum+MER MMDOAY6125MER MMDOAY61252018-08-10
00850011007068BluRapids™TNR CDOA6125TNR CDOA61252016-08-15
00850011007075BluRapids™TNR CDOA5125A3TNR CDOA5125A32016-08-15
00850011007082BluRapids™TNR CDOA7125TNR CDOA71252016-08-15
00850011007099BluRapids™TNR MMC12MOPTNR MMC12MOP2016-08-15
00850011007105BluRapids™TNR CDOA2135TNR CDOA21352016-08-15
00850011007112BluRapids™TNR CDOA7125A3TNR CDOA7125A32016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.LCM2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.LCM2026-10-14
06942598249376One Step® Fentanyl(FYL1) Urine Test PanelHangzhou AllTest Biotech Co., Ltd.DJG2026-10-12
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LDJ2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LCM2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.LAF2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIS2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28