RealityCHECK Drugs of Abuse Cup RC12TCA

GUDID 00868401000254

(BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G.

Wolfe & Associates Inc

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	00868401000254
NIH Device Record Key	3685cf4b-eb23-4aa6-84bd-b23442cfd0ac
Commercial Distribution Status	In Commercial Distribution
Brand Name	RealityCHECK Drugs of Abuse Cup
Version Model Number	RC12TCA
Catalog Number	RC12TCA
Company DUNS	189236664
Company Name	Wolfe & Associates Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx
Phone	1-855-588-3767
Email	xxx@xx.xx

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868401000254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K113046

FDA Product Code

DJR	Enzyme Immunoassay, Methadone

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-01

On-Brand Devices [RealityCHECK Drugs of Abuse Cup]

00868401000261	(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
00868401000254	(BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G.