Drugs of Abuse Five (5) Panel Test RAP-3773

GUDID 00840239037732

The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test based on immunochromatography. It is designed for the qualitative determination of 5 drug substances, specifically Amphetamine, Benzodiazepine, Cocaine, Opiate, and Cannabinoid in human urine specimens.

DRG International Inc

Multiple drugs of abuse IVD, kit, thin layer chromatography
Primary Device ID00840239037732
NIH Device Record Key0984b4be-6be6-40d1-9e1a-d09e396afc38
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrugs of Abuse Five (5) Panel Test
Version Model NumberRAP-3773
Catalog NumberRAP-3773
Company DUNS075150847
Company NameDRG International Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com
Phone+1(973)564-7555
Emailcorp@drg-international.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840239037732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme immunoassay, amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-30
Device Publish Date2019-06-10

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