DrugCheck 61013

GUDID B298610130

DrugCheck NxStep OnSite Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-

Express Diagnostic Int'l, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device IDB298610130
NIH Device Record Key895047ac-84e1-4c96-9027-7d731ce9fd60
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrugCheck
Version Model Number61013
Catalog Number61013
Company DUNS015875273
Company NameExpress Diagnostic Int'l, Inc.
Device Count1
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

Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB298610130 [Primary]

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-23
Device Publish Date2021-08-13