RealityCHECKTM

GUDID 10868401000244

Wolfe & Associates Inc

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10868401000244
NIH Device Record Key5928af60-2ba0-4f22-b633-c143655a22c4
Commercial Distribution Discontinuation2018-04-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRealityCHECKTM
Version Model NumberRC12KC
Company DUNS189236664
Company NameWolfe & Associates Inc
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
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

Customer Support Contacts

Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx
Phone855-588-3676
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100868401000247 [Unit of Use]
GS110868401000244 [Primary]

FDA Product Code

LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-01-27
Device Publish Date2016-09-24

On-Brand Devices [RealityCHECKTM]

10868401000244RC12KC
10868401000237RC05AC
10868401000220RC10KC
10868401000213RC05ACA
10868401000206RC05AF

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