Five Panel PreScreen Plus Cup (CLIA Waived)

GUDID 10851000007141

Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | OPI | PCP | THC

MERGERS MARKETING, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10851000007141
NIH Device Record Key00374845-67a1-48f9-bc96-d41309bce8d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFive Panel PreScreen Plus Cup (CLIA Waived)
Version Model NumberPSC-DOA-154
Company DUNS065602744
Company NameMERGERS MARKETING, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851000007137 [Primary]
GS100851000007144 [Package]
Contains: 00851000007137
Package: Inner Pack [25 Units]
In Commercial Distribution
GS110851000007141 [Package]
Contains: 00851000007144
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-27

On-Brand Devices [Five Panel PreScreen Plus Cup (CLIA Waived)]

10851000007141Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | OPI | PCP | THC
00850557007546Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BZO | COC | MET | MOR | THC
00850557007423Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC

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