FDA.reportPublic FDA data

Single Panel Pre Screen Plus Dip Card

Primary DI
10851000007097
Brand
Single Panel Pre Screen Plus Dip Card
Company
MERGERS MARKETING, INC.
Model
PS-ETG
Device description
Single Panel Pre Screen Plus Dip Card Drug Combo: ETG
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DOJPotassium Dichromate, Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DOJPotassium Dichromate, AlcoholClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851000007090PackageGS125In Commercial Distribution
10851000007097PackageGS120In Commercial Distribution
00851000007083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851000007090008510000070908510000070900851000007090
1085100000709710851000007097
00851000007083008510000070838510000070830851000007083

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
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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
00851000007083Single Panel Pre Screen Plus Dip CardMERGERS MARKETING, INC.DOJ2016-08-31